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Recall Observatory FDA recall evidence

Device product

Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410

Z-1332-2021

February 25, 2021

Class I

Product summary

Firm
Tenacore LLC
Event
Event 87470
Status
Terminated
Classification
Class I
Quantity
1494
Official record key
device-enforcement:Z-1332-2021

Official wording

Reason: 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.

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

Distribution pattern: US distribution to states of: WA, AZ, NY, TX, LA, CA, NV, ME, MN, DE, NC, FL, MO, KY, TN, and PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.