0 — Class I medical device recall Z-0511-2024
Ongoing recall by Nurse Assist, LLC, reported 2023-12-27, distributed nationwide. Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have t
| Recall number | Z-0511-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nurse Assist, LLC, Haltom City, TX, United States |
| Recall initiated | 2023-11-06 |
| Classified | 2023-12-20 |
| Reported by FDA | 2023-12-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 61,740 cases |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 20810062438895, 20850020865042, 20885632389754, 20885632389761, 20885632389778 |
| Lot numbers | 1203-BP/B1501203BP4/22022797, 1205-BP/B1501205BP4/22022789, 1210-BP/B1501210BP4/21112359, 21112384, 21112388, 21112441, 21112451, 21122519, 21122550, 21122572, 21122573, 21122588, 21122614, 22012632, 22012668, 22012669, 22012672, 22012673, 22012677, 22012678, 22012689, 22012690, 22022824, 22022827, 22022853, 22022857, 22032891, 22032922, 22032923, 22032935, 22032936, 22032937, 22032938, 22032962, 22032963, 22033016, 22033026, 22033038, 22033061, 22033083 and 117 more |
Product
0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP; SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001; HALYARD OWENS MINOR: 0.9% USP SODIUM CHLORIDE INJECTION/SS003, 0.9% USP SODIUM CHLORIDE INJECTION/SS005, 0.9% USP SODIUM CHLORIDE INJECTION/SS010, 10ML SYRINGE STERILE/SS010SFR
Reason for recall
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
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-0511-2024. 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.