Sterile Water/Saline: Brand Name: Product Name/Product Code:… — Class I medical device recall Z-0513-2024
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-0513-2024 |
|---|---|
| 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 | 31,850 cases |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00612479133761, 00612479168541, 00612479168558, 00612479168565, 00612479168572, 00612479168589, 00612479168596, 00612479180307, 00612479180314, 00612479228399, 00612479228405, 00612479228429, 00850421008907, 00850421008914, 10850421008744, 10850421008751, 10850421008768, 10850421008775, 10850421008782, 10850421008799, 10850421008812, 10850421008829, 10850421008836, 10850421008843, 10850421008867 and 25 more |
| Lot numbers | 10000/50192253044520/22073713, 1020/50192253044490/21122619, 1022/50192253044506/22012651, 1024/50192253044513/21122618, 210SAL/10884521139756/22022771, 21102310, 21102312, 21112381, 21112401, 21112413, 21112421, 21112423, 21112457, 21112458, 21112460, 21112463, 21112464, 21112465, 21122501, 21122504, 21122516, 21122517, 21122518, 21122527, 21122528, 21122529, 21122531, 21122546, 21122547, 21122548, 21122553, 21122555, 21122564, 21122565, 21122574, 21122575, 21122577, 21122591, 21122592, 21122598 and 460 more |
Product
Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE SALINE BOTTLE/1022, 100ML STERILE WATER BOTTLE/1024, 100ML STERILE WATER BOTTLE/10000, 100ML STERILE WATER BOTTLE/PT00103419, 100ML STERILE SALINE BOTTLE/PT00103427; COVIDIEN: STERILE WOUND SOLUTION/90SAL, STERILE WOUND SOLUTION/210SAL; HAYLARD OWENS MINOR: 250ML STERILE WATER BOTTLE/49148, 250ML STERILE SALINE BOTTLE/49152, 1000ML STERILE SALINE BOTTLE/49154, 100ML STERILE SALINE BOTTLE/49155, 1000ML STERILE WATER BOTTLE/49150, 100ML STERILE WATER BOTTLE/49151, 500ML STERILE WATER BOTTLE/49149, 500ML STERILE SALINE BOTTLE/49153; IDEXX: BOTTLE STERILE WATER 10 PACK/98-09444-01; MCKESSON: 100ML STERILE SALINE BOTTLE/37-6240, 500ML STERILE WATER BOTTLE/37-6290, 250ML STERILE SALINE BOTTLE/37-6270, 500ML STERILE SALINE BOTTLE/37-6280, 120ML STERILE WATER CUP/37-6210, 1000ML STERILE SALINE BOTTLE/37-6281, 1000ML STERILE WATER BOTTLE/37-6291, 120ML STERILE SALINE CUP/37-6220, 100ML STERILE WATER BOTTLE/37-6250, 250ML STERILE WATER BOTTLE/37-6260, 210ML SALINE WOUND FLUSH/37-6507, 88.7ML SALINE WOUND FLUSH STERILE/37-6503; MEDICHOICE OWENS MINOR: CAN STERILE SALINE SPRY MEDI 7.1 OZ/SWF071; MEDLINE: 110ML STERILE SALINE CUP/DYND40540, 100ML STERILE SALINE BOTTLE/RDI30296, 250ML STERILE WATER BOTTLE/PCS1550, 250ML STERILE SALINE BOTTLE/PCS1650, 1000ML STERILE SALINE BOTTLE/DYND1000MLS, 100ML STERILE SALINE BOTTLE/52011, 500ML STERILE WATER BOTTLE/DYND500MLW, 500ML STERILE SALINE BOTTLE/DYND500MLS, 100ML STERILE WATER BOTTLE/RDI30295, CAN SALINE STERILE SPRAY CURAD/CURSALINE7, 110ML STERILE WATER CUP/DYND40570, 100ML STERILE WATER BOTTLE/54380; NURSE ASSIST: 100ML STERILE SALINE BOTTLE/6492775, 100ML STERILE WATER BOTTLE/6492776; STERICARE: 90ML USP SALINE WOULD FLUSH/6503, 100ML STERILE SALINE BOTTLE/6240, 100ML STERILE WATER BOTTLE/6250, 250ML STERILE SALINE BOTTLE/6270, 500ML STERILE WATER BOTTLE/6290, 250ML STERILE WATER BOTTLE/6260, 500ML STERILE SALINE BOTTLE/6280, 1000ML STERILE SALINE BOTTLE/6281, 1000ML STERILE WATER BOTTLE/6291, 210ML SALINE WOUND FLUSH/6507, 120ML STERILE SALINE FOIL LID CUP/6220, 120ML STERILE WATER FIOL LID CUP/6210, 500ML STERILE WATER BOTTLE/5290, 500ML STERILE SALINE BOTTLE/5280; VYAIRE: CUP STERILE SALINE FOIL LID 120 ML/4873C
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-0513-2024. 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.