Sterile Water: Product Name/Product Code: USP STERILE WATER… — Class I medical device recall Z-0515-2024
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-0515-2024 |
|---|---|
| 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 | 15,800 cases |
| Reason classes | sterility |
| Lot numbers | 1010/B15010104/22063386, 1030/B15010304/22032995, 1030A/B1501030A4/2001155, 1812001, 2003041, 2005126, 2008103, 2102502, 2102567, 2102580, 2102600, 22012631, 22012674, 22012712, 22012715, 22022735, 22022790, 22022814, 22022825, 22022858, 22032880, 22032882, 22032931, 22032961, 22043126, 22043146, 22043168, 22043213, 22053248, 22053339, 22053358, 22063498, 22073735, 22114309, 22114358, 22114363, 23014570, 23014586, 23014593, 23014630 and 10 more |
Product
Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010
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-0515-2024. 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.