FDA Device recall Z-0514-2024
Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005
- FDA Device
- Class I
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class I recall of Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005 by Nurse Assist, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0514-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-11-06 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Nurse Assist |
| Distribution | US |
Product
Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID 120 ML/T167007
Reason
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.
Identifiers
| code_info | Product Code/Lot: T167005/22022859, 22083878, 23055524; T167007/21122503, 22022860, 22083862, 22114365, 23045255, 23045267 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0514-2024%22
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