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

Recall Z-0097-2019 — Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets

U.S. FDA — Device Enforcement · United States · 2018-09-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0097-2019
Date of alert
2018-09-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bayer Medical Care, Inc.
Product category
device
Product type
Devices
Reported risk: Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may potentially enter the fluid path.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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