CLASS II Device recall · Reported 17 Oct 2018 · FDA Enforcement Report
Codan Filter (Codan recalled by Bayer Medical Care
Bayer Medical Care is recalling Codan Filter (Codan, distributed nationwide in the US. The recall was initiated on 7 Sep 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0097-2019
- FDA event ID
- 80945
- Recalling firm
- Bayer Medical Care, Indianola, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Sep 2018
- FDA classified
- 11 Oct 2018
- Reported
- 17 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Infusion Pumps
Timeline
| 7 Sep 2018 | Recall initiated by company | |
| 11 Oct 2018 | Classified by FDA | +34 days |
| 17 Oct 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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
Where it was distributed
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
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasLouisianaMassachusettsMaineMichiganMinnesotaMissouri
Questions about this recall
Why was it 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.
Which lots 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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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