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

Recall Z-1678-2013 — Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous deliv

U.S. FDA — Device Enforcement · United States · 2009-07-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1678-2013
Date of alert
2009-07-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Baxter Healthcare Corp.
Product category
device
Product type
Devices
Reported risk: There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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