Medline Kits — Class I medical device recall Z-1112-2024
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-1112-2024 |
|---|---|
| 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 | 21,154 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00653160203691, 00653160271454, 00653160292008, 00653160325645, 00653160348309, 00653160348828, 00653160351880, 00653160351897, 00653160352160, 00653160353211, 10080196778690, 10193489110869, 10193489111712, 10193489111897, 10193489440270, 10193489440713, 10653160203698, 10653160271451, 10653160292005, 10653160325642, 10653160348306, 10653160348825, 10653160351887, 10653160351894, 10653160352167 and 7 more |
| Lot numbers | 2021121750, 2022010450, 2022012050, 2022012450, 2022020250, 2022022880, 2022041150, 2022041880, 2022042580, 2022042850, 2022050280, 2022051050, 2022051350, 2022053150, 2022061380, 2022061480, 2022072750, 2022082280, 22ABH461, 22ABJ736, 22EBB078, 22EBI572, 22FBE772, 22FBG265, 22FBK706, 22FBU120, 22GBI140, 22GBJ917, 22GBZ790, 22HBK650, 22HBN681, 22HBW656, 22JBB835, 22JBT097, 22KBW287, 22LBS262, 22LBS268, 23ABL668, 23CBH315, 23CBV894 and 18 more |
| Model numbers | DT20900A, DYNDA2369A, DYNDA2659A, DYNDA2660A, DYNDC2816C, DYNDC2869B, DYNDC3188, DYNDH1650, DYNDS1085A, EBSI1302A, UT13535, UT13935, UT15380, UT19005, UT21215, UVT840A |
Product
Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d) LACERATION TRAY W/SNAGFREE NEE, REF SUT19005; e) PLASTICS SUTURE TRAY, REF SUT13535; f) UVC INSERTION TRAY, REF UVT840A g) BRONCHOALVEOLAR LAVAGE PACK, REF DYNDA2369A; h) CENTRAL LINE NEEDLELESS CONNECTOR KIT, REF DYNDC2869B; i) CVC STERILE CAP CHANGE KIT, REF DT20900A; j) DOUBLE VALVE CHANGE KIT, REF DYNDA2660A; k) KIDNEY BIOPSY PACK, REF DYNDH1650; l) PORT ACCESS INFUSION KIT - 0.75IN NEEDLE, REF DYNDC2816C; m) PORT ACCESS KIT, REF EBSI1302A; n) SHORT TERM INFUSAPORT ACCESS KIT, REF DYNDC3188; o) SINGLE VALVE CHANGE KIT, REF DYNDA2659A; p) SUTURE TRAY, REF DYNDS1085A;
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-1112-2024. 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.