Medline Kits — Class I medical device recall Z-1128-2024
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-1128-2024 |
|---|---|
| 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 | 1,012,700 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10080196032617, 10080196033577, 10080196033607, 10080196033621, 10080196033652, 10080196033669, 10080196033676, 10080196996537, 40080196032618, 40080196033578, 40080196033608, 40080196033622, 40080196033653, 40080196033660, 40080196033677, 40080196996538 |
| Lot numbers | 2022031590, 2022032290, 2022040590, 2022042590, 2022042690, 2022042790, 2022042890, 2022051890, 2022052790, 2022053190, 2022060290, 2022060690, 2022062290, 2022062390, 2022070190, 2022070590, 2022070690, 2022072290, 2022072590, 2022072690, 2022072790, 2022072890, 2022080890, 2022082390, 2022082490, 2022082590, 2022090690, 2022090790, 2022093090, 2022100690, 2022100790, 2022101090, 2022101190, 2022102490, 2022102590, 2022121290, 2022121390, 2022121990, 2022122090, 2022122890 and 26 more |
| Model numbers | 10FR, 12FR, 14FR, 18FR, 6FR, 8FR, DYND40442, DYND41442, DYND41470, DYND41471, DYND41472, DYND41474, DYND41476, DYND41478, W/H20 |
Product
Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471; c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442; d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472; e) KIT,SUCTION CATH,18FR W/H20, REF DYND41474; f) KIT,SUCTION CATH,6FR,DELEE,W/H, REF DYND41476; g) KIT,SUCTION CATH,8FR DELEE W/H, REF DYND41478; h) KIT,SUCTION CATHETER,14FR W/S, REF DYND41442
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-1128-2024. 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.