MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; ...
FDA Device Recall #Z-1102-2024 — Class I — November 15, 2023
Recall Summary
| Recall Number | Z-1102-2024 |
| 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 | 3297 units |
Product Description
MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NURSE BAG KIT, REF DYKM1425; d) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; e) GASTRIC CULTURE PACK, REF DYNJ53966A; f) GASTRIC CULTURE PACK, REF DYNJ53966AH; g) HERNIA, REF CDS982034R; h) HERNIA, REF CDS982034S; i) HERNIA PACK, REF DYNJ39331B; j) LAP APPY PACK, REF DYNJ37709J; k) LAP CHOLE CDS, REF CDS983912V; l) LAP CHOLE CDS, REF CDS983912W; m) LAP CHOLE CDS, REF CDS983912X; n) LAP CHOLE CDS, REF CDS983912Y; o) LAPAROSCOPY PACK, REF DYNJ41417J; p) LAPAROTOMY CDS-LF, REF CDS860091A; q) LOWER EXTREMITY, REF DYNJ46222M; r) MAJOR PACK, REF DYNJ80578A; s) MINOR PACK, REF DYNJ67217D; t) N L MINOR CDS, REF CDS982518O; u) N L MINOR CDS, REF CDS982518P; v) NON STERILE I&D KIT, REF DYKM1438; w) PACK,GU MINOR, REF DYNJ906885B; x) PLASTICS SUTURE TRAY, REF SUT13535; y) RESPIRATORY KIT, REF DYKM1404; z) TRACH CARE TRAY, REF DYNDJ1057A;
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 CDS983673G, UDI/DI 40193489951746 (case), 10193489951745 (unit), Lot Numbers: 22EDA378, 22EDB208; b) REF CDS983673I, UDI/DI 40195327147335 (case), 10195327147334 (unit), Lot Numbers: 22GBJ096, 22GBJ097, 22HBR769, 22KBN934, 23ABH521, 23ABM586, 23BBR709, 23DBL344; c) REF DYKM1425, UDI/DI 40889942511236 (case), 10889942511235 (unit), Lot Numbers: 22DLA695, 22FLA284, 22GLA016, 22ILA012, 22ILA463, 22KLA336, 23ALA341, 23BLA132, 23DLB048, 23ELA454, 23FLA774, 23HLA165, 23ILB030, 23JLA435; d) REF DT18700, UDI/DI 653160275087 (case), 10653160275084 (unit), Lot Numbers: 23EBC489; e) REF DYNJ53966A, UDI/DI 40889942964681 (case), 10889942964680 (unit), Lot Numbers: 23CMB869, 23DMG880, 23EMG449, 23FMC889, 23HMA233, 23IMD181; f) REF DYNJ53966AH, UDI/DI 40889942964681 (case), 10889942964680 (unit), Lot Numbers: 23CMB869, 23DMG880, 23EMG449, 23FMC889, 23HMA233, 23IMD181, g) REF CDS982034R, UDI/DI 40195327003740 (case), 10195327003739 (unit), Lot Numbers: 21LBB488, 21LBC635, 22HBW422; h) REF CDS982034S, UDI/DI 40195327295364 (case), 10195327295363(unit), Lot Numbers: 23ABB710, 23BBA114, 23EBB482; i) REF DYNJ39331B, UDI/DI 40889942731580 (case), 10889942731589 (unit), Lot Numbers: 22HBH194, 22JBE708, 22LBL321, 23GBV891, 23IBA384; j) REF DYNJ37709J, UDI/DI 40193489376075 (case), 10193489376074 (unit), Lot Numbers: 22FMG179; k) REF CDS983912V, UDI/DI 40195327057146 (case), 10195327057145 (unit), Lot Numbers: 22BBX974, 22DBG451, 22DBO438, 22FBM809; l) REF CDS983912W, UDI/DI 40195327238408 (case), 10195327238407 (unit), Lot Numbers: 22KBI248, 23CBC518, 23DBM244; m) REF CDS983912X, UDI/DI 40195327403141 (case), 10195327403140 (unit), Lot Numbers: 23EBK644; n) REF CDS983912Y, UDI/DI 40195327417827 (case), 10195327417826 (unit), Lot Numbers: 23FBS625, 23HBD741, 23HBO315, 23IBC397, 23IBM310; o) REF DYNJ41417J, UDI/DI 40195327220991 (case), 10195327220990 (unit), Lot Numbers: 23FBQ267; p) REF CDS860091A, UDI/DI 40884389018324 (case), 10884389018323 (unit), Lot Numbers: 22ABW443, 22CBU907, 22FMA320, 22GMH940, 22IMI179, 22KMA029, 23AMJ550, 23CMF095, 23FMI870, 23GMF353; q) REF DYNJ46222M, UDI/DI 40195327437566 (case), 10195327437565 (unit), Lot Numbers: 23GBP791; r) REF DYNJ80578A, UDI/DI 40195327063819 (case), 10195327063818 (unit), Lot Numbers: 22FBO880; s) REF DYNJ67217D, UDI/DI 40195327278022 (case), 10195327278021 (unit), Lot Numbers: 23DBC699, 23EBB789, 23GBC854, 23GBP633; t) REF CDS982518O, UDI/DI 40195327247387 (case), 10195327247386 (unit), Lot Numbers: 23ABD137; u) REF CDS982518P, UDI/DI 40195327318858 (case), 10195327318857 (unit), Lot Numbers: 23BBM210; v) REF DYKM1438, UDI/DI 40889942529965 (case), 10889942529964 (unit), Lot Numbers: 22DDB583, 22FDA732, 22HDA409, 22JDA278, 22LDA778, 23BDB559, 23FDC186, 23IDA954; w) REF DYNJ906885B, UDI/DI 40193489972543 (case), 10193489972542 (unit), Lot Numbers: 22GBF087; x) REF SUT13535, UDI/DI 40193489440271 (case), 10193489440270 (case), Lot Numbers: 23GBD750; y) REF DYKM1404, UDI/DI 40889942473831 (case), 10889942473830 (unit), Lot Numbers: 22JBQ565, 23CBG138, 23EBO035, 23EBW986, 23GBP589; z) REF DYNDJ1057A, UDI/DI 40888277204790 (case), 10888277204799 (unit), Lot Numbers: 23DBC974
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.