Recall Z-0514-2024— Nurse Assist, LLC
Class I · Ongoing
Class I FDA medical device recall by Nurse Assist, LLC, initiated 2023-11-06. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Nurse Assist, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-11-06
- Firm location
- Haltom City, TX, United States
Product description
Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID 120 ML/T167007
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.