Z-1332-2021 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 14, 2021
- Initiation Date
- February 25, 2021
- Termination Date
- August 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1494
Product Description
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Reason for Recall
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.
Distribution Pattern
US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA
Code Information
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