Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1332-2021 — Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410

U.S. FDA — Device Enforcement · United States · 2021-02-25 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1332-2021
Date of alert
2021-02-25
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Tenacore LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.