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Recall Observatory FDA recall evidence

Device 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

Z-0097-2019

September 07, 2018

Class II

Product summary

Firm
Bayer Medical Care, Inc.
Event
Event 80945
Status
Terminated
Classification
Class II
Quantity
1,142,836 (329,944 units in U.S.)
Official record key
device-enforcement:Z-0097-2019

Official wording

Reason: 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.

Code information: 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

Distribution pattern: 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

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate