Physio-Control, Inc.: PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 0072190268

Hazard

Due to pediatric defibrillator electrode delamination

Details from the source

Reason for recall: Due to pediatric defibrillator electrode delamination Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Hong Kong, Japan, Mexico, Malaysia, Netherlands, New Zealand, and Taiwan. Quantity: 16,499 electrodes (US/OUS: 8327/8172) Lot/code info: Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Lot Numbers: 315303, 315639, 315858, 316007, 320529, 318931

UPC codes

00721902629013, 00721902682483

Source

Official record: FDA (Device enforcement) ↗

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