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Nurse Assist, LLC recalls 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV F
Recalled December 27, 2023 · FDA recall Z-0511-2024 · Nurse Assist
Hazard
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. · FDA Class I
Units
61,740 Cases
Sold at
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
Description
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.
Product
0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP; SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001; HALYARD OWENS MINOR: 0.9% USP SODIUM CHLORIDE INJECTION/SS003, 0.9% USP SODIUM CHLORIDE INJECTION/SS005, 0.9% USP SODIUM CHLORIDE INJECTION/SS010, 10ML SYRINGE STERILE/SS010SFR
Manufacturer(s)
Nurse Assist, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →