FDA Medical Device Recalls (openFDA)
Bayer Medical Care, Inc.: 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
- Recall number
- Z-0097-2019
- Recalling firm
- Bayer Medical Care, Inc.
- 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
- Status
- Terminated
- Initiated
- 2018-09-07
- Posted
- not on file
- Terminated
- 2019-07-11
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- Urgent Medical Device Recall notification letters dated 9/7/18 were distributed to customers. The letters instruct customers to do the following: 1. Immediately discontinue use of your Intego system and quarantine the unused PAS product until further notice. 2. Contact Bayer Customer Care at 1-800-633-7231 opt. 2 or ricustomercare@bayer.com to receive a Return Goods Authorization (RGA) number and return the Codan Filters to Bayer accordingly. 3. Complete the response form indicating if your institution does or does not have affected product. Return the form via fax (1-412-406-0942) or email (randicommercialquality@bayer.com).
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K830755"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2520313
- Firm city
- Indianola
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28