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

Recall Z-1309-2021 — BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.

U.S. FDA — Device Enforcement · United States · 2021-03-03 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1309-2021
Date of alert
2021-03-03
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
CareFusion 303, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
49000239
Reported risk: Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay
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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