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FDA (Device enforcement)Recalled 2023-11-06class i

Nurse Assist, LLC: 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240

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.

Details from the source

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. Distribution: 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 Quantity: 3,360 Cases Lot/code info: Product Code/UDI-DI/Lot: EMZ10091240/20363807109166/21112364, 21112439, 21112455, 21122507, 21122551, 21122576, 21122593, 21122609, 21122617, 22012635, 22073671, 22094119, 22104179, 22104234

UPC codes

20363807109166

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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