Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Reason for recall: Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser. Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, IL, IN, KS, KY, MA, ME, MN, NC, ND, NJ, NM, OH, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hungary, Korea (the Republic of), Latvia, Malaysia. Quantity: 136 sets Lot/code info: Model Number: 902-00038. UDI-DI: 00896128002220. Lot Number: 20241013
00896128002220
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.