Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAI...
FDA Device Recall #Z-1117-2024 — Class I — November 15, 2023
Recall Summary
| Recall Number | Z-1117-2024 |
| 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 |
| Quantity | 86699 units |
Product Description
Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c) DRESSING CHANGE TRAY, REF DYNDC3131A; d) DRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e) DRSG CHANGE TRAY W/ CHG, REF DT21460B; f) DRSG CHANGE TRAY W/ CHG, REF DT21460BH; g) LVAD MANAGEMENT SYSTEM - ACUTE, REF DM580; h) LVAD MANAGEMENT SYSTEM - ACUTE, REF DM580H; i) PEDIATRIC PORT KIT W/ DRESSING, REF DYNDC3120A; j) PORT ACCESS DRSG KIT W OUT CHG, REF DYNDC3081; k) PORT ACCESS DRSG KIT WITH CHG, REF DYNDC3080; l) PORT ACCESS PACK-LF, REF DYNJ0352159D; m) PORT DRESSING CHANGE KIT, REF DT22810; n) PORT DRESSING CHANGE TRAY, REF DT20640B; o) PORT DRESSING CHANGE TRAY, REF DYNDC3052A; p) PORT DRESSING CHANGE TRAY, REF DYNDC3052AH; q) POST OP,20-DAY SUPPLY 40/CS, REF DYKM1528; r) POST OP,20-DAY SUPPLY 40/CS, REF DYKM1528H; s) SALINE GAUZE DRESSING TRAY, REF DYNDA2937; t) SALINE GAUZE DRESSING TRAY, REF DYNDA2937A; u) SALINE GAUZE DRESSING TRAY, REF DYNDA2937AH; v) ADULT MEDIPORT DRESSING KIT, REF DYNDC3161; w) A-LINE/PORT DRESSING CHANGE KIT, REF EBSI1530; x) CENTRAL LINE DRESSING CHANGE KIT, REF EBSI1489; y) CENTRAL LINE DRESSING KIT, REF EBSI1088A; z) CENTRAL LINE DRESSING KIT, REF EBSI1088B; aa) CENTRAL LINE KIT, REF EBSI1245B; bb) CENTRAL LINE/PICC DRESSING CHANGE SYSTEM, REF DYNDC2925B; cc) CVC DRESSING CHANGE KIT, REF EBSI1472A; dd) CVC/PICC DRESSING CHANGE KIT, REF EBSI1110C; ee) CVL DRESSING CHANGE KIT, REF EBSI1547; ff) DIALYSIS CHANGE KIT, REF EBSI1453; gg) DIALYSIS KIT, REF EBSI1476; hh) DRESSING CHANGE KIT WITH CHLORAPREP, REF EBSI1413A; ii) DRESSING CHANGE TRAY, REF EBSI1513; jj) EBSI DRESSING CHANGE KIT, REF EBSI1163B; kk) ERASE BSI CENTRAL LINE DRSNG CHNG KIT, REF EBSI1415A; ll) ERASE BSI CVC DRSNG CHNGE KIT, REF EBSI1161A; mm) IJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; nn) IJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; oo) LARGE BORE DRESSING CHANGE KIT, REF EBSI1555; pp) OUTPATIENT INFUSION DRSG CHNG, REF DYNDC3135; qq) OUTPATIENT PORT ACCESS TRAY, REF DT22500A; rr) PACK CHEST PORT KIT INPATIENT, REF DYNDC3087; ss) PICC DRESSING CHANGE KIT, REF EBSI1471A; tt) PICC DRESSING CHANGE TRAY, REF EBSI1512; uu) PICC DRESSING CHANGE TRAY, REF EBSI1546; vv) PICC/CENTRAL LINE DRESSING CHANGE TRAY, REF EBSI1486; ww) PICC/MIDLINE DRESSING CHANGE TRAY, REF EBSI1523; xx) PORT ACCESS TRAY, REF DYNDC2703A; yy) PORT DRESSING CHANGE KIT, REF EBSI1434A; zz) PORT DRESSING CHANGE KIT, REF EBSI1525; aaa) PORT DRESSING CHANGE KIT, REF EBSI1525; bbb) PORT DRESSING CHANGE TRAY, REF EBSI1208A; ccc) SMALL BORE DRESSING CHANGE KIT, REF EBSI1556
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 CVI4705, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23FMD562; b) REF DT18700, UDI/DI 653160275087 (case), 10653160275084 (unit), Lot Numbers; 23BBJ923, 23CBB549, 23FBM548, 23GBF094, 23GBR827, 23HBM237; c) REF DYNDC3131A, UDI/DI 40195327105694 (case), 10195327105693 (unit), Lot Numbers: 22CBJ619, 22DBD254, 22IBG214; d) DT17405A, UDI/DI 40653160991619 (case), 10653160991618 (unit), Lot Numbers: 22CBY954, 22DBB495, 22DBH244, 22HBT273; e) DT21460B, UDI/DI 40653160991572 (case), 10653160991571 (unit), Lot Numbers: 22ABZ051, 22OBC041; f) DT21460BH, UDI/DI 40653160991572 (case), 10653160991571 (unit), Lot Numbers: 22ABZ051, 22OBC041; g) DM580, UDI/DI 653160286984 (case), 10653160286981 (unit), Lot Numbers: 22EBB241, 22FBE733, 22JBR597, 23ABL651, 23BBB038, 23CBU481, 23FBD719, 23GBN340, 23IBE764, 23IBT300; h) DM580H, UDI/DI 653160286984 (case), 10653160286981 (unit), Lot Numbers: 22EBB241, 22FBE733, 22JBR597, 23ABL651, 23BBB038, 23CBU481, 23FBD719, 23GBN340, 23IBE764, 23IBT300; i) DYNDC3120A, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23AME583, 23FMC905; j) DYNDC3081, UDI/DI 40193489849746 (case), 10193489849745 (unit), Lot Numbers: 22CBG508; k) DYNDC3080, UDI/DI 40193489849739 (case), 10193489849738 (unit), Lot Numbers: 22BBR416, 2EBD704; l) DYNJ0352159D, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23AME774; m) DT22810, UDI/DI 40653160993361 (case), 10653160993360 (unit), Lot Numbers: 22IBI823; n) DT20640B, UDI/DI 40653160991671 (case), 10653160991670 (unit), Lot Numbers: 22ABT093, 22JBB214; o) DYNDC3052A, UDI/DI 40195327160129 (case), 10195327160128 (unit), Lot Numbers: 22LMI145; p) DYNDC3052AH, UDI/DI 40195327160129 (case), 10195327160128 (unit), Lot Numbers:22LMI145; q) DYKM1528, UDI/DI 40889942689928 (case), 10889942689927 (unit), Lot Numbers: 22HBZ240, 22KBR167; r) DYKM1528H, UDI/DI 40889942689928 (case), 10889942689927 (unit), Lot Numbers: 22HBZ240, 22KBR167; s) DYNDA2937, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers: 22JBK727, 22JBT535, 23CBX574; t) DYNDA2937A, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers:23DBF619, 23EBK506, 23FBF438, 23HBN471, 23IBN607; u) DYNDA2937AH, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers: 23EBK506, 23FBF438, 23HBN471, 23IBN607 v) REF DYNDC3161, UDI/DI 20193489111627 (case), 10193489111620 (unit), Lot Numbers: 2022031480, 2022061380, 2022082980; w) REF EBSI1530, UDI/DI 00653160354195 (case), 10653160354192 (unit), Lot Numbers: 2022082280; x) REF EBSI1489, UDI/DI 20193489111238 (case), 10193489111231 (unit), Lot Numbers: 2022011350, 2022022880, 2022082280; y) REF EBSI1088A, UDI/DI 20193489111726 (case), 10193489111729 (unit), Lot Numbers: 2022022180; z) REF EBSI1088B, UDI/DI 00653160352689 (case), 10653160352686 (unit), Lot Numbers: 2022061380, 2022082280; aa) REF EBSI1245B, UDI/DI 20193489110828 (case), 10193489110821 (unit), Lot Numbers: 2022031480, 2022082280; bb) REF DYNDC2925B, UDI/DI 00653160349832 (case), 10653160349839 (unit), Lot Numbers: 2022012450, 2022021050, 2022022180; cc) REF EBSI1472A, UDI/DI 20193489112594 (case), 10193489112597 (unit), Lot Numbers: 2021122950, 2022021480; dd) REF EBSI1110C, UDI/DI 00653160352269 (case), 10653160352266 (unit), Lot Numbers: 2022052380; ee) REF EBSI1547, UDI/DI 00653160352276 (case), 10653160352273 (unit), Lot Numbers: 2022050980; ff) REF EBSI1453, UDI/DI 20193489110194 (case), 10193489110197 (unit), Lot Numbers: 2022022180, 2022032880; gg) REF EBSI1476, UDI/DI 20193489110156 (case), 10193489110159 (unit), Lot Numbers: 2022012480, 2022082280; hh) REF EBSI1413A, UDI/DI 20193489112198 (case), 10193489112191 (unit), Lot Numbers: 2022031480; ii) REF EBSI1513, UDI/DI 20193489112617 (case), 10193489112610 (unit), Lot Numbers: 2021122950, 2022012480; jj) REF EBSI1163B, UDI/DI 20193489112112 (case), 10193489112115 (unit), Lot Numbers: 2022050980, 2022061380; kk) REF EBSI1415A, UDI/DI 20193489112235 (case), 10193489112238 (unit), Lot Numbers: 2022021650; ll) REF EBSI1161A, UDI/DI 20193489111801 (case), 10193489111804 (unit), Lot Numbers: 2022012480, 2022022880, 2022082280; mm) REF EBSI1524, UDI/DI 00653160349238 (case), 10653160349235 (unit), Lot Numbers: 2021122950, 2022082280; nn) REF EBSI1524, UDI/DI 00653160350784 (case), 10653160350781 (unit), Lot Numbers: 2021122950, 2022082280; oo) REF EBSI1555, UDI/DI 00653160354508 (case), 10653160354505 (unit), Lot Numbers: 2022082280; pp) REF DYNDC3135, UDI/DI 20193489111221 (case), 10193489111224 (unit), Lot Numbers: 2022032180, 2022040480, 2022061380, 2022062080, 2022082280; qq) REF DT22500A, UDI/DI 00653160349795 (case), 10653160349792 (unit), Lot Numbers: 2022020850, 2022050950, 2022061380; rr) REF DYNDC3087, UDI/DI 20193489110477 (case), 10193489110470 (unit), Lot Numbers: 2022013180, 2022020180, 2022020280; ss) REF EBSI1471A, UDI/DI 20193489112600 (case), 10193489112603 (unit), Lot Numbers: 2021121750, 2022020780; tt) REF EBSI1512, UDI/DI 20193489112624 (case), 10193489112627 (unit), Lot Numbers: 2022013180; uu) REF EBSI1546, UDI/DI 00653160352283 (case), 10653160352280 (unit), Lot Numbers: 2022050280; vv) REF EBSI1486, UDI/DI 20193489111184 (case), 10193489111187 (unit), Lot Numbers: 2022041880, 022082280; ww) REF EBSI1523, UDI/DI 00653160349191 (case), 10653160349198 (unit), Lot Numbers: 2021122950, 2022040480; xx) REF DYNDC2703A, UDI/DI 00653160348675 (case), 10653160348672 (unit), Lot Numbers: 2022012480, 2022061380; yy) REF EBSI1434A, UDI/DI 00653160348620 (case), 10653160348627 (unit), Lot Numbers: 2021122150, 2022012480, 2022061380; zz) REF EBSI1525, UDI/DI 00653160349214 (case), 10653160349211 (unit), Lot Numbers: 2021122950; aaa) REF EBSI1525, UDI/DI 00653160350791 (case), 10653160350798 (unit), Lot Numbers: 2021122950; bbb) REF EBSI1208A, UDI/DI 00653160349047 (case), 10653160349044 (unit), Lot Numbers: 2022021480, 2022082280; ccc) REF EBSI1556, UDI/DI 00653160354492 (case), 10653160354499 (unit), Lot Numbers: 2022082280
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.