MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b)...
FDA Device Recall #Z-1097-2024 — Class I — November 15, 2023
Recall Summary
| Recall Number | Z-1097-2024 |
| Classification | Class I — Serious risk |
| Date Initiated | November 15, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
Product Description
MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DYNDC2723A; e) CAP CHANGE KIT, REF DYNDC2723B; f) CENTRAL LINE INSERTION PACK, REF CVI4805; g) CENTRAL LINE TRAY, REF CVI4705; h) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721A; i) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721B; j) CVC INSERTION PACK, REF CVI4720; k) CVC INSERTION PACK, REF CVI4720A; l) CVC INSERTION PACK, REF CVI4720AH; m) DERM SURG CUSTOM PACK, REF DYNDA1584C; n) ER CENTRAL LINE KIT, REF P155508D; o) FISTULA GRAFT KIT, REF DT20345A; p) IMPLANTED PORT ACCESS, REF DYNDC2765B; q) IVAD KIT, REF DYNDC2004B; r) KIT LINE INSERTION, REF CVI4730H; s) KIT LINE INSERTION, REF CVI4730; t) LINE CHANGE KIT, REF DYNDC2927A; u) MAX BARRIER PACK, REF DYNJ50717; v) MEDIPORT W/CHG, REF DYNDC2219B; w) MEDIPORT W/CHG, REF DYNDC2219BH; x) NICU PICC INSERTION KIT, REF CVI4395B; y) PACK,CENTRAL LINE, REF DYNJ906907B; z) PEDI CENTRAL LINE AND PORT ACC, REF DT19740A; aa) PEDS INFANT LUMBAR PUNCTURE, REF DYNDH1636; bb) PEDS/ NICU LINE KIT, REF MNS13555; cc) PICC LINE PACK, REF DYNJ64249A; dd) PICC LINE TRAY, REF DYNDC2170; ee) PORT ACCESS KIT, REF DYNDC3251; ff) PORT ACCESS KIT, REF DYNDC3251H; gg) PORT ACCESS KIT, REF DYNDC3252; hh) PORT ACCESS SUPPLIES, REF DYNDA2142B; ii) PORT ACCESS TRAY, REF DYNDC2449B; jj) PORT ACCESS TRAY, REF DYNDC3066; kk) PORT ACCESS TRAY, REF DYNDC3103; ll) PORT ACCESS/LAB KIT, REF DYNDC3129A; mm) PORT ACCESS/LAB KIT, REF DYNDC3129AH; nn) PORT FULL ACCESS TRAY, REF DT19330B; oo) PORT KIT, REF DT22785; pp) PORT KIT W/ HUBER NEEDLE, REF DT22780; qq) PORT-A-CATH ACCESS KIT, REF DYNDC1994C; rr) PORT-A-CATH ACCESS KIT, REF DYNDC1994D; ss) PORT-A-CATH ACCESS KIT, REF DYNDC1994DH; tt) SUBCLAVIAN PORT ACCESS, REF DYNDC2555C; uu) USG PIV INSERTION KIT, REF DYNDV2480; vv) USG PIV INSERTION KIT, REF DYNDV2480H; ww) VAD DRESSING CHANGE TRAY, REF DYNDC2078; xx) VAD DRESSING CHANGE TRAY, REF DYNDC2078H; yy) VAD DRESSING CHANGE TRAY, REF DYNDC2657A; zz) VAD KIT WITHOUT VALVES, REF DYNDC3179; aaa) VEIN CLOSURE PACK, REF DYNJ69976
Reason for Recall
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Distribution Pattern
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Lot / Code Information
a) REF DYNJ65208A, UDI/DI 40195327120598 (case), 10195327120597 (unit), Lot Numbers: 23CMB532, 23CME753, 23EMD721, 23FMH948; b) REF DT22710, UDI/DI 40653160990636 (case), 10653160990635 (unit), Lot Numbers: c) REF DYNDC2002A, UDI/DI 21LBV542, 22CBM841, 22IBG132; d) REF DYNDC2723A, UDI/DI 40193489999236 (case), 10193489999235 (unit), Lot Numbers: 22ABH235, 22BBF113, 22IBG479; e) REF DYNDC2723B, UDI/DI 40195327007028 (case), 10195327004255 (unit), Lot Numbers: 22ABZ109, 22BBK108; f) REF CVI4805, UDI/DI 40195327068715 (case), 10195327068714 (unit), Lot Numbers: 22ABP582, 22CBP735, 22JBK237, 22LBK168; g) REF CVI4705, UDI/DI 40193489832373 (case), 10193489832372 (unit), Lot Numbers: 22CMF740, 22LMH493, 23BMA064, 23HMH653; h) REF DYNDC2721A, UDI/DI 40195327007080 (case), 10195327005313 (unit), Lot Numbers: 21LBK271, 22ABS686; i) REF DYNDC2721B, UDI/DI 40195327111091 (case), 10195327111090 (unit), Lot Numbers: 22CBS571, 22DBO302, 22IBG350; j) REF CVI4720, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23CLA574, 23DLA197; k) REF CVI4720A, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23DLA715, 23ELB184, 23GLA187; l) REF CVI4720AH, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23DLA715, 23ELB184, 23GLA187; m) REF DYNDA1584C, UDI/DI 40195327194506 (case), 10195327194505 (unit), Lot Numbers: 22HBB107, 22JBH444, 22KBN619, 22KBU753, 23ABH824, 23CBS036, 23EBD658, 23GBH542, 23IBI230; n) REF P155508D, UDI/DI 40193489899062 (case), 10193489899061 (unit), Lot Numbers: 22DMC487, 23AMB416, 23BMF491, 23FMD563; o) REF DT20345A, UDI/DI 40653160991565 (case), 10653160991564 (unit), Lot Numbers: 22ABJ804, 22BBA095, 22IBG184, 22OBE089; p) REF DYNDC2765B, UDI/DI 40195327039500 (case), 10195327039509 (unit), Lot Numbers: 22ABJ710, 22CBV307, 22CBX726, 22OBA248; q) REF DYNDC2004B, UDI/DI 40193489999335 (case), 10193489999334 (unit), Lot Numbers: 22ABH197, 22ABK671, 22BBE950, 22DBG182, 22GBD995; r) REF CVI4730, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers: 22BBB180, 22CBX813, 22JBV916, 22KBD924, 22LBN849, 23ABF976, 23BBG923, 23CBN830; s) REF CVI4730H, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers: 22ABA994, 22BBB180, 22CBX813, 22JBV916, 22KBD924, 22LBN849, 23ABF976, 23BBG923, 23CBN830; t) REF DYNDC2927A, UDI/DI 40193489943420 (case), 10193489943429 (unit), Lot Numbers: 22BBW666, 22HBT170; u) REF DYNJ50717, UDI/DI 40889942032373 (case), 10889942032372 (unit), Lot Numbers: 22ABY200, 22HBH109; v) REF DYNDC2219B, UDI/DI 40195327007073 (case), 10195327006068 (unit), Lot Numbers: 22ABN425, 22ABU632, 22BBE945, 22GBA060, 22IBH187; w) REF DYNDC2219BH, UDI/DI 40195327007073 (case), 10195327006068 (unit), Lot Numbers: 22ABN425, 22ABU632, 22BBE945, 22GBA060, 22IBH187; x) REF CVI4395B, UDI/DI 40653160991633 (case), 10653160991632 (unit), Lot Numbers: 21LBV562, 22CBV268; y) REF DYNJ906907B, UDI/DI 40195327303526 (case), 10195327303525 (unit), Lot Numbers: 23BMF842; z) REF DT19740A, UDI/DI 40653160992524 (case), 10653160992523 (unit), Lot Numbers: 22EBE126, 22HBC049, 22IBG224; aa) REF DYNDH1636, UDI/DI 40193489934879 (case), 10193489934878 (unit), Lot Numbers: 22BBG415, 22DBE305, 22MBA761; bb) REF MNS13555, UDI/DI 40653160991954 (case). 10653160991953 (unit), Lot Numbers: 22CBE020, 22EBP942; cc) REF DYNJ64249A, UDI/DI 40193489381369 (case), 10193489381368 (unit), Lot Numbers: 22FLA161; dd) REF DYNDC2170, UDI/DI 40888277919100 (case), 10888277919099 (unit), Lot Numbers: 22HBO758, 22IBE630, 22LBP013, 23BBF471, 23BBL514, 23GBA859, 23JBD576; ee) REF DYNDC3251, UDI/DI 40195327219056 (case), 10195327219055 (unit), Lot Numbers: 22IBG587; ff) REF DYNDC3251H, UDI/DI 40195327219056 (case), 10195327219055 (unit), Lot Numbers: 22IBG587 gg) REF DYNDC3252, UDI/DI 40195327221141 (case), 10195327221140 (unit), Lot Numbers: 22IBG588; hh) REF DYNDA2142B, UDI/DI 40195327134168 (case), 10195327134167 (unit), Lot Numbers: 22DBG180, 22EMC030; ii) REF DYNDC2449B, UDI/DI 40195327010745 (case), 10195327010744 (unit), Lot Numbers: 21LBT939, 22EBP926, 22FBT224; jj) REF DYNDC3066, UDI/DI 40193489824644 (case), 10193489824643 (unit), Lot Numbers: 22CBD170; kk) REF DYNDC3103, UDI/DI 40193489962438 (case), 10193489962437 (unit), Lot Numbers: 22HBT222, 22IBG493, 22MBA063; ll) REF DYNDC3129A, UDI/DI 40195327009831 (case), 10195327009830 (unit), Lot Numbers: 22BBM598, 22CBZ667, 22DMC594, 22DME352; mm) REF DYNDC3129AH, UDI/DI 40195327009831 (case), 10195327009830 (unit), Lot Numbers: 22BBM598, 22CBZ667, 22DMC594, 22DME352; nn) REF DT19330B, UDI/DI 40653160992371 (case), 10653160992370 (unit), Lot Numbers: 22OBC582, 22OBE354; oo) REF DT22785, UDI/DI 40653160992326 (case), 10653160992325 (unit), Lot Numbers: 22CBP076, 22CBS504; pp) REF DT22780, UDI/DI 40653160992364 (case), 10653160992363 (unit), Lot Numbers: 22DBD209; qq) REF DYNDC1994C, UDI/DI 40195327083428 (case), 10195327083427 (unit), Lot Numbers: 22ABJ752, 22ABZ148, 22DBD308; rr) REF DYNDC1994D, UDI/DI 40195327211715 (case), 10195327211714 (unit), Lot Numbers: 22HBT161; ss) REF DYNDC1994DH, UDI/DI 40195327211715 (case), 10195327211714 (unit), Lot Numbers: 22HBT161; tt) REF DYNDC2555C, UDI/DI 40195327123421 (case), 10195327123420 (unit), Lot Numbers: 22OBE207; uu) REF DYNDV2480, UDI/DI 40193489942768 (case), 10193489942767 (unit), Lot Numbers: 22BMG253, 22CMF718, 22CMF720, 22GMB111; vv) REF DYNDV2480H, UDI/DI 40193489942768 (case), 10193489942767 (unit), Lot Numbers: 22BMG253, 22CMF718, 22CMF720, 22GMB111; ww) REF DYNDC2078, UDI/DI 40888277262301 (case), 10888277262300 (unit), Lot Numbers: 22EBV407, 22FBL375, 22GBF171; xx) REF DYNDC2078H, UDI/DI 40888277262301 (case), 10888277262300 (unit), Lot Numbers: 22EBV407, 22FBL375, 22GBF171; yy) REF DYNDC2657A, UDI/DI 40193489492973 (case), 10193489492972 (unit), Lot Numbers: 22FBU096, 22HBO094, 22IBT553, 23BBI094, 23EBD054, 23FBA804; zz) REF DYNDC3179, UDI/DI 40195327021444 (case), 10195327021443 (unit), Lot Numbers: 22ABK983, 22ABO532; aaa) REF DYNJ69976, UDI/DI 40195327000654 (case), 10195327001308 (unit), Lot Numbers: 22BBW440
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 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.