MEDLINE Kits — Class I medical device recall Z-1102-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-03-06, distributed nationwide. Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse
| Recall number | Z-1102-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2023-11-15 |
| Classified | 2024-02-24 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, PA |
| Quantity | 3,297 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00653160275087, 10193489376074, 10193489440270, 10193489951745, 10193489972542, 10195327003739, 10195327057145, 10195327063818, 10195327147334, 10195327220990, 10195327238407, 10195327247386, 10195327278021, 10195327295363, 10195327318857, 10195327403140, 10195327417826, 10195327437565, 10653160275084, 10884389018323, 10888277204799, 10889942473830, 10889942511235, 10889942529964, 10889942731589 and 24 more |
| Lot numbers | 21LBB488, 21LBC635, 22ABW443, 22BBX974, 22CBU907, 22DBG451, 22DBO438, 22DDB583, 22DLA695, 22EDA378, 22EDB208, 22FBM809, 22FBO880, 22FDA732, 22FLA284, 22FMA320, 22FMG179, 22GBF087, 22GBJ096, 22GBJ097, 22GLA016, 22GMH940, 22HBH194, 22HBR769, 22HBW422, 22HDA409, 22ILA012, 22ILA463, 22IMI179, 22JBE708, 22JBQ565, 22JDA278, 22KBI248, 22KBN934, 22KLA336, 22KMA029, 22LBL321, 22LDA778, 23ABB710, 23ABD137 and 51 more |
| Model numbers | CDS860091A, CDS982034R, CDS982034S, CDS982518O, CDS982518P, CDS983673G, CDS983673I, CDS983912V, CDS983912W, CDS983912X, CDS983912Y, DT18700, DYKM1404, DYKM1425, DYKM1438, DYNDJ1057A, DYNJ37709J, DYNJ39331B, DYNJ41417J, DYNJ46222M, DYNJ53966A, DYNJ53966AH, DYNJ67217D, DYNJ80578A, DYNJ906885B and 1 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1102-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.