Bayer Recalls Codan Filters Due to Potential Particulate Contamination
Bayer is recalling Codan Filters used in IV administration sets because the dust cap may generate particulate that enters the fluid path.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where particulate may enter the fluid path, representing a risk-of-harm product where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Bayer Medical Care, Inc. is recalling Codan Filters (catalog number BC 693) used with Medrad Patient Administration Sets and Intego PET Infusion Systems. The recall involves 1,142,836 units worldwide, including 329,944 units in the United States.
The recall was initiated after Bayer received reports of loose particulate in the filter when the dust cap is removed. Further testing confirmed that the dust cap may generate particulate which may potentially enter the fluid path.
The affected products were distributed nationwide in the United States and in numerous foreign countries. Consumers and healthcare facilities should stop using the affected filters and contact Bayer for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Bayer Medical Care, Inc.
Distribution
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