Nurse Assist product recalled over sterility concerns

Recall date

November 6, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Nurse Assist, LLC recalls Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFIL…

Recall number

Z-0515-2024

FDA classification

Class I

Brand / firm

Nurse Assist, LLC

Sold / distributed

US Nationwide Distribution: SC AZ, CA, FL, GA, HI, IA, IN, KS, KY, MA, ME, MN, MS, NC, ND, NE, NJ, NV, NY, OH, PA, RI, TX, WA, WI, AK, AL, AR, CO, CT, DC, ID, IL, LA, MD, MI, MO, MT, NH, NM, OK, OR, PR, SD, TN, UT, VA , WI, WV, WY. OUS (foreign) distribution to: Canada

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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