FDASeptember 7, 2018device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
bayer medical carebayerbayer medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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