Cardinal Health 200, LLC: Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single 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: 58742 Lot/code info: UDI-DI (ea) 10192253040302; UDI-DI (box) 50192253040300 Lots 2431300157 2431300158 2431300156 2431300154 2431300153 2433300197 2431300152 2418100101 2433300200 2418300064 2432300069 2417000115 2431800139 2432200143 2432600251 2417000116 2433300199 2418100103 2432300066 2418300063 2433300195 2432600250 2430300087 2433300193 2430300085 2417000113 2433300201 2432200139 2429900138 2412300004 2430300083 2430300086 2430300084 2418100102 2431300155

UPC codes

10192253040302, 50192253040300

Source

Official record: FDA (Device enforcement) ↗

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