Tenacore LLC: Medical Device Recall in 2021 - (Recall #: Z-1332-2021)
See the recall detail below. You can also see other recalls from the same firm in 2021.
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Class I
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.
Parts distributed between July 10, 2020 and January 22, 2021. Time stamp at bezel rear side shows 5 or 6 SO Numbers: 271111, 263873, 264442, 264890, 268606, 269930, 270760, 270936, 271211, 272860, 267603, 268936, 269258, 269291, 272496, 272225, 271408, 267392
US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA
Voluntary: Firm initiated