Codan Filter recall: Particulate Matter
Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2…
Why was Codan Filter 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch Numbers 14888 72498 72789 74023 75221 17061 72501 72790 74161 75277 20046 72529 72990 74162 75278 20056 72541 73365 74568 75434 70091 72639 73372 74569 75435 72354 72677 73600 74570 75482 72362 72713 73827 74571 75603 72365 72714 73944 74758 75625 72422 72788 74022 75220 75733
- Product
- Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2…
- Recalling firm
- Bayer Medical Care, Inc.
- Quantity
- 1,142,836 (329,944 units in U.S.)
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, and WI. Foreign countries: UAE, Austria, Australia, Bosnia and Herzegovina, Belgium, Bahrain, Canada, China, Chile, Costa Rica, Czechia, Denmark, German, Spain, Estonia, Egypt, Finland, France, Great Britain, Croatia, Hungary, Israel, Italy, Jordan, Kuwait, Kazakhstan, Lebanon, Lithuania, Morocco, Malta, Mexico, Netherlands, Norway, Oman, Panama, Poland, Portugal, Romania, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, and Turkey
- Recall date
- October 17, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)