Medline Kits — Class I medical device recall Z-1127-2024
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-1127-2024 |
|---|---|
| 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 | 14,280 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489281460, 10193489351736, 10193489351781, 10193489402759, 10193489424539, 10193489433883, 10193489433906, 10193489440362, 10193489821635, 10193489828955, 10193489876826, 10193489916164, 10193489917369, 10193489934106, 10195327111953, 10195327112806, 10195327141196, 10195327222086, 10195327238339, 10195327257590, 10195327257620, 10195327280673, 10195327280895, 10195327375690, 10195327375782 and 44 more |
| Lot numbers | 21KBI896, 22ABK059, 22ABP606, 22ALA255, 22BBU107, 22BBV355, 22BDB050, 22CBS838, 22CDC277, 22DBB588, 22DDA444, 22EBI104, 22EBN387, 22EBP166, 22EBU873, 22EDB075, 22EDB527, 22FBA911, 22FBD779, 22FBG492, 22FBL484, 22FBR327, 22FBU866, 22FDB578, 22GBI467, 22GBL600, 22GBM602, 22HBA403, 22HBH536, 22HBO484, 22HBS428, 22IBA206, 22IBE726, 22IBO503, 22IMA552, 22JBN895, 22JBQ099, 22JBQ342, 22JBW455, 22KBG879 and 85 more |
| Model numbers | CDS941004C, CDS981656I, CDS981658G, CDS981659I, CDS981659J, CDS982823P, CDS982823Q, CDS983313I, CMPJ06038F, CMPJ06038G, CMPJ06040D, CMPJ06040F, DYNDH1629, DYNJ34648D, DYNJ35744A, DYNJ46211K, DYNJ46222M, DYNJ48587A, DYNJ55335D, DYNJ64576A, DYNJ64814A, DYNJ67216C, DYNJ67216D, DYNJ68347A, DYNJ68347B and 15 more |
Product
Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1629; c) CVL INSERTION KIT-LF, REF DYNJ48587A; d) EXTREMITY CDS, REF CDS983313I; e) EXTREMITY CDS, REF DYNJ902004D; f) EXTREMITY CDS, REF DYNJ902004F; g) EXTREMITY IV, REF CMPJ06040D; h) EXTREMITY IV, REF CMPJ06040F; i) EXTREMITY PROCEDURE, REF CDS981656I; j) FACIAL PLASTY PACK, REF DYNJ55335D; k) FOOT PROCEDURE, REF CDS981659I; l) FOOT PROCEDURE, REF CDS981659J; m) HAND, REF DYNJ902002J; n) HAND PACK, REF DYNJ35744A; o) HAND PACK, REF DYNJ68873C; p) HAND PACK, REF DYNJ46211K; q) KNEE ARTHROSCOPY CDS, REF CDS941004C; r) KNEE PACK, REF DYNJ68512; s) LACERATION TRAY, REF SUT21580; t) LOWER EXTREMITY, REF DYNJ907121F; u) LOWER EXTREMITY, REF DYNJ46222M; v) LOWER EXTREMITY PACK, REF DYNJ67216C; w) LOWER EXTREMITY PACK, REF DYNJ67216D; x) PACK,POSTERIOR SPINAL FUSION, REF DYNJ906892; y) PODIATRY PACK, REF DYNJ68347A; z) PODIATRY PACK, REF DYNJ68347B; aa) PODIATRY PACK-LF, REF DYNJ34648D; bb) POSTERIOR PACK, REF DYNJ64576A; cc) SHOULDER, REF DYNJ903011J; dd) SHOULDER ARTHROTOMY PROCEDURE, REF CDS981658G; ee) SHOULDER KIT, REF DYNJ907705D; ff) SMALL HAND CDS, REF DYNJ902002G; gg) SMALL HAND CDS, REF DYNJ902002I; hh) SMALL HAND PACK, REF CMPJ06038F; ii) SMALL HAND PACK, REF CMPJ06038G; jj) TOTAL KNEE, REF DYNJ909159; kk) TOTAL KNEE CDS, REF CDS982823P; ll) TOTAL KNEE CDS, REF CDS982823Q; mm) TRIGGER FINGER KIT, REF DYNJ68406; nn) UPPER EXTREMITY, REF DYNJ907130C
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-1127-2024. 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.