Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
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: 1710 Lot/code info: UDI-DI (ea) 10192253040296; UDI-DI (box) 50192253040294 Lots 2433100060 2433100059 2422700145 2422700139 2422700146 2422700142
10192253040296, 50192253040294
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.