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: 370 Lot/code info: UDI-DI (ea) 10192253040289; UDI-DI (box) 50192253040287 Lot 2502400146
10192253040289, 50192253040287
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.