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FDA (Device enforcement)Recalled 2025-05-02class ii

Cardinal Health 200, LLC: Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen

Hazard

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

Details from the source

Reason for recall: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa. Quantity: 10438 Lot/code info: UDI-DI (ea) 10192253040364; UDI-DI (box) 50192253040362 Lots 2424900133 2424900134 2424900135 2435200126 2435200127 2435200129 2435200123 2435200124

UPC codes

10192253040364, 50192253040362

Source

Official record: FDA (Device enforcement)

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

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