Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , C...

FDA Device Recall #Z-0913-2025 — Class II — November 8, 2024

Recall Summary

Recall Number Z-0913-2025
Classification Class II — Moderate risk
Date Initiated November 8, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cardinal Health 200, LLC
Location Waukegan, IL
Product Type Devices
Quantity 512,786 total units

Product Description

Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSMEA; 2 ) KIT, NASAL , Catalog Number: PE23NSMEC; 3 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number: PE23SENLA; 4 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number: PE23SENLC; 5 ) KIT, EAR , Catalog Number: PE30EAGT6; 6 ) KIT, EAR , Catalog Number: PE30EAGT7; 7 ) KIT, EAR , Catalog Number: PE30EAGT8; 8 ) KIT, EAR , Catalog Number: PE30EAGT9; 9 ) KIT, EAR , Catalog Number: PE30EAGTB; 10 ) KIT, EAR , Catalog Number: PE30EAGTC; 11 ) KIT, EAR , Catalog Number: PE30EAGTD; 12 ) KIT, NASAL , Catalog Number: PE35NSB10; 13 ) KIT, NASAL , Catalog Number: PE35NSB11; 14 ) KIT, NASAL , Catalog Number: PE35NSB12; 15 ) KIT, NASAL , Catalog Number: PE35NSB13; 16 ) KIT, NASAL , Catalog Number: PE35NSB14; 17 ) KIT, NASAL , Catalog Number: PE35NSB15; 18 ) KIT, NASAL , Catalog Number: PE35NSB16; 19 ) KIT, NASAL , Catalog Number: PE35NSB17; 20 ) KIT, NASAL , Catalog Number: PE35NSB18; 21 ) KIT NASAL , Catalog Number: PE35NSB19; 22 ) KIT, NASAL , Catalog Number: PE35NSBL1; 23 ) KIT, NASAL , Catalog Number: PE35NSBL2; 24 ) KIT, NASAL , Catalog Number: PE35NSBL3; 25 ) KIT, NASAL , Catalog Number: PE35NSBL4; 26 ) KIT, NASAL , Catalog Number: PE35NSBL5; 27 ) KIT, NASAL , Catalog Number: PE35NSBL6; 28 ) KIT, NASAL , Catalog Number: PE35NSBL7; 29 ) KIT, NASAL , Catalog Number: PE35NSBL8; 30 ) KIT, NASAL , Catalog Number: PE35NSBL9; 31 ) KIT, NASAL , Catalog Number: PE35NSBLA; 32 ) KIT, NASAL , Catalog Number: PE35NSBLB; 33 ) KIT, NASAL , Catalog Number: PE35NSBLC; 34 ) KIT NASAL , Catalog Number: PE35NSBLD; 35 ) KIT, NASAL , Catalog Number: PE35NSBLF; 36 ) KIT, SINUS , Catalog Number: PE3ESKSG1; 37 ) KIT, SINUS , Catalog Number: PE3ESKSG2; 38 ) KIT, SINUS , Catalog Number: PE3ESKSGA; 39 ) KIT, SINUS , Catalog Number: PE3ESKSGB; 40 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU4; 41 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU5; 42 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU6; 43 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU7; 44 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAUH; 45 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAUI; 46 ) KIT, SEPTOPLASTY , Catalog Number: PEDHSPNH3; 47 ) KIT, SEPTOPLASTY , Catalog Number: PEDHSPNHE; 48 ) KIT,ORP MAJOR EAR , Catalog Number: PEHDMJVCG; 49 ) KIT,ENT, SW , Catalog Number: PEMHETMHA; 50 ) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMH1; 51 ) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMH2; 52 ) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHA; 53 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSB10; 54 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSB11; 55 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH4; 56 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH5; 57 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH6; 58 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH7; 59 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH8; 60 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH9; 61 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBHP; 62 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBHQ; 63 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBHR; 64 ) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL011; 65 ) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL012; 66 ) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL01A; 67 ) KIT,NASAL SINUS ,PRESBYTERIAN , Catalog Number: PEV2CL102; 68 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL103; 69 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL104; 70 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL105; 71 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL106; 72 ) KIT,NASAL SINUS , PRESBYTERIAN , C

Reason for Recall

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Lot / Code Information

Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 6928769 ; Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 7160527 ; Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 7163103 ; Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 7280105 ; Catalog Number PE23NSMEC, UDI/DI 10197106644829 (EA)50197106644827 (CS), Lot Number 7332911 ; Catalog Number PE23NSMEC, UDI/DI 10197106644829 (EA)50197106644827 (CS), Lot Number 7332915 ; Catalog Number PE23SENLA, UDI/DI 10197106543351 (EA)50197106543359 (CS), Lot Number 7160537 ; Catalog Number PE23SENLA, UDI/DI 10197106543351 (EA)50197106543359 (CS), Lot Number 7331341 ; Catalog Number PE23SENLA, UDI/DI 10197106543351 (EA)50197106543359 (CS), Lot Number 7332910 ; Catalog Number PE23SENLC, UDI/DI 10197106760956 (EA)50197106760954 (CS), Lot Number 7332917 ; Catalog Number PE30EAGT6, UDI/DI 10195594668167 (EA)50195594668165 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGT7, UDI/DI 10195594725600 (EA)50195594725608 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGT8, UDI/DI 10195594774950 (EA)50195594774958 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGT9, UDI/DI 10197106038192 (EA)50197106038190 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 22D1239 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 22D1239 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 19A0125 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 19A0125 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 18J2583 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 19B0516 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 19L3475 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 19E1526 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number XV2 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTC, UDI/DI 10197106667309 (EA)50197106667307 (CS), Lot Number 24C0657 ; Catalog Number PE30EAGTD, UDI/DI 10197106733622 (EA)50197106733620 (CS), Lot Number 22D1239 ; Catalog Number PE35NSB10, UDI/DI 10195594540302 (EA)50195594540300 (CS), Lot Number 5664101 ; Catalog Number PE35NSB11, UDI/DI 10195594565909 (EA)50195594565907 (CS), Lot Number 5891306 ; Catalog Number PE35NSB12, UDI/DI 10197106027165 (EA)50197106027163 (CS), Lot Number 6025791 ; Catalog Number PE35NSB13, UDI/DI 10197106236963 (EA)50197106236961 (CS), Lot Number 6596396 ; Catalog Number PE35NSB14, UDI/DI 10197106285398 (EA)50197106285396 (CS), Lot Number 6487901 ; Catalog Number PE35NSB15, UDI/DI 10197106310618 (EA)50197106310616 (CS), Lot Number 6563988 ; Catalog Number PE35NSB16, UDI/DI 10197106322390 (EA)50197106322398 (CS), Lot Number 6788560 ; Catalog Number PE35NSB17, UDI/DI 10197106365939 (EA)50197106365937 (CS), Lot Number 6806113 ; Catalog Number PE35NSB18, UDI/DI 10197106418710 (EA)50197106418718 (CS), Lot Number 6806115 ; Catalog Number PE35NSB19, UDI/DI 10197106702574 (EA)50197106702572 (CS), Lot Number 7332911 ; Catalog Number PE35NSBL1, UDI/DI 10888439745771 (EA)50888439745779 (CS), Lot Number J3464F ; Catalog Number PE35NSBL2, UDI/DI 10888439759099 (EA)50888439759097 (CS), Lot Number J1896M ; Catalog Number PE35NSBL3, UDI/DI 10195594038878 (EA)50195594038876 (CS), Lot Number J8124C ; Catalog Number PE35NSBL4, UDI/DI 10195594120542 (EA)50195594120540 (CS), Lot Number J6050H ; Catalog Number PE35NSBL5, UDI/DI 10195594268176 (EA)50195594268174 (CS), Lot Number 5405628 ; Catalog Number PE35NSBL6, UDI/DI 10195594400392 (EA)50195594400390 (CS), Lot Number 5533334 ; Catalog Number PE35NSBL7, UDI/DI 10195594424862 (EA)50195594424860 (CS), Lot Number 5533336 ; Catalog Number PE35NSBL8, UDI/DI 10195594454494 (EA)50195594454492 (CS), Lot Number J6278U ; Catalog Number PE35NSBL9, UDI/DI 10195594492496 (EA)50195594492494 (CS), Lot Number 5664102 ; Catalog Number PE35NSBLA, UDI/DI 10888439647693 (EA)50888439647691 (CS), Lot Number J4952G ; Catalog Number PE35NSBLB, UDI/DI 10888439767360 (EA)50888439767368 (CS), Lot Number J53W68 ; Catalog Number PE35NSBLB, UDI/DI 10888439767360 (EA)50888439767368 (CS), Lot Number J5679K ; Catalog Number PE35NSBLB, UDI/DI 10888439767360 (EA)50888439767368 (CS), Lot Number J8064Z ; Catalog Number PE35NSBLB, UDI/DI 10888439767360 (EA)50888439767368 (CS), Lot Number J84K01 ; Catalog Number PE35NSBLB, UDI/DI 10888439767360 (EA)50888439767368 (CS), Lot Number J85W28 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 6563989 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 6914943 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 6928764 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number J6050H ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 5891311 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 5891310 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 5970334 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 5631071 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 5891315 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 6264565 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 6345522 ; Catalog Number PE35NSBLD, UDI/DI 10197106568828 (EA)50197106568826 (CS), Lot Number 7280105 ; Catalog Number PE35NSBLD, UDI/DI 10197106568828 (EA)50197106568826 (CS), Lot Number 7280106 ; Catalog Number PE35NSBLD, UDI/DI 10197106568828 (EA)50197106568826 (CS), Lot Number 7332906 ; Catalog Number PE35NSBLF, UDI/DI 10197106764299 (EA)50197106764297 (CS), Lot Number 7332913 ; Catalog Number PE3ESKSG1, UDI/DI 10195594388850 (EA)50195594388858 (CS), Lot Number 5533333 ; Catalog Number PE3ESKSG2, UDI/DI 10195594885793 (EA)50195594885791 (CS), Lot Number J6278R ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 6560946 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number J85H45 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5135984 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5664102 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5664101 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5891308 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5891310 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5891312 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5891313 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 6025787 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 6025788 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 6264569 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 6345523 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 24-04 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7332913 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7332916 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 6701853 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 6806113 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 6914942 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 6928758 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 6928765 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7163033 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7163103 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7127056 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7287567 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7331341 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7332910 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7332913 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7332915 ; Catalog Number PECGNAAU4, UDI/DI 10195594396022 (EA)50195594396020 (CS), Lot Number 5618932 ; Catalog Number PECGNAAU5, UDI/DI 10195594483487 (EA)50195594483485 (CS), Lot Number 5631074 ; Catalog Number PECGNAAU6, UDI/DI 10195594566210 (EA)50195594566218 (CS), Lot Number 5891306 ; Catalog Number PECGNAAU7, UDI/DI 10195594698812 (EA)50195594698810 (CS), Lot Number 5891313 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J3464F ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J43U74 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J31U57 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J46C02 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J4952C ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J34J42 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J5679K ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J7963G ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J84K03 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J8671K ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number N/A ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J8692Y ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J8693A ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J86T83 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J85W23 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number 5140346 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number 5140342 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number 5664102 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number 5876883 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number 5891308 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 7332916 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6560945 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6596397 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6914942 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6788562 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6788562 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928762 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928766 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928769 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928773 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 7160537 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 7163033 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928771 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928767 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 7332904 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928770 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6025785 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 5631069 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6345521 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6345522 ; Catalog Number PEDHSPNH3, UDI/DI 10888439697575 (EA)50888439697573 (CS), Lot Number J4952D ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J43U74 ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J30T39 ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J4952G ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J5678Z ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J5679F ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J5679M ; Catalog Number PEHDMJVCG, UDI/DI 10888439780963 (EA)50888439780961 (CS), Lot Number 19L3475 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6560944 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6701853 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6928757 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6928759 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7163033 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7280108 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7280109 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7287567 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7332903 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7332904 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7332914 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7332913 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 5631073 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 5891304 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 5891315 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6264570 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6345522 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6560943 ; Catalog Number PEMHNFMH1, UDI/DI 10197106643495 (EA)50197106643493 (CS), Lot Number 7280109 ; Catalog Number PEMHNFMH2, UDI/DI 10197106679180 (EA)50197106679188 (CS), Lot Number 6914945 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 6563989 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 6928771 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 5664101 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 5891306 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 5891307 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number J6367H ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 6264565 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 6264566 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 6487901 ; Catalog Number PEMHNSB10, UDI/DI 10197106092972 (EA)50197106092970 (CS), Lot Number 6487902 ; Catalog Number PEMHNSB11, UDI/DI 10197106417195 (EA)50197106417193 (CS), Lot Number 6806115 ; Catalog Number PEMHNSBH4, UDI/DI 10888439572605 (EA)50888439572603 (CS), Lot Number J3464F ; Catalog Number PEMHNSBH5, UDI/DI 10888439581683 (EA)50888439581681 (CS), Lot Number J3464F ; Catalog Number PEMHNSBH6, UDI/DI 10195594950057 (EA)50195594950055 (CS), Lot Number J8693A ; Catalog Number PEMHNSBH7, UDI/DI 10195594244033 (EA)50195594244031 (CS), Lot Number 5140342 ; Catalog Number PEMHNSBH8, UDI/DI 10195594520809 (EA)50195594520807 (CS), Lot Number 5618933 ; Catalog Number PEMHNSBH9, UDI/DI 10195594563059 (EA)50195594563057 (CS), Lot Number 5664101 ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J46A99 ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J4952D ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J53W68 ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J6050D ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J8064Z ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J8124C ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J8671K ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J8693A ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number N/A ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J9602T ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number N/A ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number 5135984 ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number 5618932 ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number 5664098 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 5747232 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 5970333 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number J6278R ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 5631071 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 6025786 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number J6278R ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 6264567 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 6345522 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6560946 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6563990 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6702012 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6788561 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6928762 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 7163033 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 7163103 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 7280106 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6914945 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 7287567 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 7332918 ; Catalog Number PEV2CL011, UDI/DI 10197106673539 (EA)50197106673537 (CS), Lot Number 7163082 ; Catalog Number PEV2CL012, UDI/DI 10197106730485 (EA)50197106730483 (CS), Lot Number 7332913 ; Catalog Number PEV2CL01A, UDI/DI 10197106651711 (EA)50197106651719 (CS), Lot Number 7332909 ; Catalog Number PEV2CL102, UDI/DI 10195594414245 (EA)50195594414243 (CS), Lot Number 5533336 ; Catalog Number PEV2CL103, UDI/DI 10195594680145 (EA)50195594680143 (CS), Lot Number 5891305 ; Catalog Number PEV2CL104, UDI/DI 10195594711849 (EA)50195594711847 (CS), Lot Number J6367H ; Catalog Number PEV2CL105, UDI/DI 10195594745806 (EA)50195594745804 (CS), Lot Number 1271519 ; Catalog Number PEV2CL105, UDI/DI 10195594745806 (EA)50195594745804 (CS), Lot Number 5631071 ; Catalog Number PEV2CL106, UDI/DI 10195594779818 (EA)50195594779816 (CS), Lot Number 6025788 ; Catalog Number PEV2CL107, UDI/DI 10195594824129 (EA)50195594824127 (CS), Lot Number 5664103 ; Catalog Number PEV2CL108, UDI/DI 10195594876166 (EA)50195594876164 (CS), Lot Number J6278R ; Catalog Number PEV2CL109, UDI/DI 10197106306628 (EA)50197106306626 (CS), Lot Number 6701853 ; Catalog Number PEV2CL10O, UDI/DI 10887488813486 (EA)50887488813484 (CS), Lot Number J46A97 ; Catalog Number PEV2CL10P, UDI/DI 10888439619140 (EA)50888439619148 (CS), Lot Number J43U74 ; Catalog Number PEV2CL10P, UDI/DI 10888439619140 (EA)50888439619148 (CS), Lot Number J43U77 ; Catalog Number PEV2CL10P, UDI/DI 10888439619140 (EA)50888439619148 (CS), Lot Number J4952G ; Catalog Number PEV2CL10Q, UDI/DI 10888439687828 (EA)50888439687826 (CS), Lot Number J53W72 ; Catalog Number PEV2CL10Q, UDI/DI 10888439687828 (EA)50888439687826 (CS), Lot Number J53W68 ; Catalog Number PEV2CL10Q, UDI/DI 10888439687828 (EA)50888439687826 (CS), Lot Number J7704F ; Catalog Number PEV2CL10Q, UDI/DI 10888439687828 (EA)50888439687826 (CS), Lot Number J8123W ; Catalog Number PEV2CL10Q, UDI/DI 10888439687828 (EA)50888439687826 (CS), Lot Number J8124A ; Catalog Number PEV2CL10S, UDI/DI 10888439967456 (EA)50888439967454 (CS), Lot Number J6367G ; Catalog Number PEV2CL10S, UDI/DI 10888439967456 (EA)50888439967454 (CS), Lot Number J6367G ; Catalog Number PEV2CL10S, UDI/DI 10888439967456 (EA)50888439967454 (CS), Lot Number J86T82 ; Catalog Number PEV2CL10T, UDI/DI 10195594180713 (EA)50195594180711 (CS), Lot Number 5140355 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 6563992 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number J1J0578Y ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 5631074 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 5631073 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 5891307 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 5891309 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 5891307 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 6264568 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 6345524 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 6563988 ; Catalog Number PEV2CL10V, UDI/DI 10197106246979 (EA)50197106246977 (CS), Lot Number 6702009 ; Catalog Number PEV2CL10V, UDI/DI 10197106246979 (EA)50197106246977 (CS), Lot Number 6914942 ; Catalog Number PEV2CL10W, UDI/DI 10197106425794 (EA)50197106425792 (CS), Lot Number 6788562 ; Catalog Number PEV2CL10W, UDI/DI 10197106425794 (EA)50197106425792 (CS), Lot Number 6914943 ; Catalog Number PEV2CL10X, UDI/DI 10197106484326 (EA)50197106484324 (CS), Lot Number 6928765 ; Catalog Number PEV2CL10X, UDI/DI 10197106484326 (EA)50197106484324 (CS), Lot Number 7160537 ; Catalog Number PEV2CL10Z, UDI/DI 10197106546789 (EA)50197106546787 (CS), Lot Number 7280105 ; Catalog Number PEV2CL10Z, UDI/DI 10197106546789 (EA)50197106546787 (CS), Lot Number 6928767 ; Catalog Number PEV2FSNYA, UDI/DI 10197106516225 (EA)50197106516223 (CS), Lot Number 7163033 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7349689 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7127056 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7280110 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7332903 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7332910 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7332916 ; Catalog Number PEV2OT10F, UDI/DI 10197106066669 (EA)50197106066667 (CS), Lot Number 6022128 ; Catalog Number PEV2OT10F, UDI/DI 10197106066669 (EA)50197106066667 (CS), Lot Number 6563990 ; Catalog Number PEV2OT10F, UDI/DI 10197106066669 (EA)50197106066667 (CS), Lot Number 6345522 ; Catalog Number PEV2OT10G, UDI/DI 10197106245163 (EA)50197106245161 (CS), Lot Number 6914944 ; Catalog Number PEV2OT10G, UDI/DI 10197106245163 (EA)50197106245161 (CS), Lot Number 6914945 ; Catalog Number PEV2OT10H, UDI/DI 10197106484418 (EA)50197106484416 (CS), Lot Number 6928765 ; Catalog Number PEV2OT10H, UDI/DI 10197106484418 (EA)50197106484416 (CS), Lot Number 7160527 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7280108 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7332917 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 6928771 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7280107 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 6928772 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7163082 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7332913 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7332917 ; Catalog Number PEX4SSMNA, UDI/DI 10197106242599 (EA)50197106242597 (CS), Lot Number 6022130 ; Catalog Number PG35NSBL1, UDI/DI 10888439569360 (EA)50888439569368 (CS), Lot Number J3464G ; Catalog Number PG35NSBLA, UDI/DI 10888439559729 (EA)50888439559727 (CS), Lot Number J3987D ; Catalog Number PG35NSBLA, UDI/DI 10888439559729 (EA)50888439559727 (CS), Lot Number J43U77 ; Catalog Number PNVMESCH8, UDI/DI 10195594436070 (EA)50195594436078 (CS), Lot Number J70X17 ; Catalog Number PNVMESCH8, UDI/DI 10195594436070 (EA)50195594436078 (CS), Lot Number 5138232 ; Catalog Number PNVMESCH9, UDI/DI 10195594457419 (EA)50195594457417 (CS), Lot Number J6278U ; Catalog Number PNVMESCH9, UDI/DI 10195594457419 (EA)50195594457417 (CS), Lot Number 5530911 ; Catalog Number PQMHETMH2, UDI/DI 10195594927462 (EA)50195594927460 (CS), Lot Number J86T81 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J3987C ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J43U74 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J43U77 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J22M99 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J4952G ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J53W72 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J5679F ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J74A30 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J7963H ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J8393W ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J85W28 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number 20-1-3 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J9602T ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J86T82 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number 5405627 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number 5533336 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number 5140343 ; Catalog Number PQMHNFMH2, UDI/DI 10195594939335 (EA)50195594939333 (CS), Lot Number J86T82 ; Catalog Number PQMHNFMH3, UDI/DI 10195594033941 (EA)

Other Recalls from Cardinal Health 200, LLC

Recall # Classification Product Date
Z-1203-2026 Class II Chest Drainage Units and Accessories: Produc... Dec 26, 2025
Z-0897-2026 Class II ChemoPlus gowns: Product Code Product Descript... Nov 12, 2025
Z-0207-2026 Class II Salem Sump PVC Tubes: Product Code/Product N... Sep 18, 2025
Z-0208-2026 Class II Salem Sump PVC Tubes: Product Code/Product N... Sep 18, 2025
Z-0211-2026 Class II Salem Sump PVC Tubes: Product Code/Product N... Sep 18, 2025

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from Cardinal Health 200, LLC Recalls by Firm Recall Reasons Device Safety Stats