Reported Oct 17, 2018 · Terminated
Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion…
Bayer Medical Care, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bayer Medical Care, Inc. · 1 Bayer Dr · Indianola, PA · 15051-9702
Is this the product you have?
- Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego
- PET Infusion Systems Product Usage1.2 micron filter for use with Intravenous Administration Sets
- Lot codes and dates
- Batch Numbers
148887249872789740237522117061725017279074161752772004672529729907416275278200567254173365745687543470091726397337274569754357235472677736007457075482723627271373827745717560372365727147394474758756257242272788740227522075733
- Batch Numbers
- Amount recalled
- 1,142,836 (329,944 units in U.S.)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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