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Lower risk Medical device recall · FDA · Published September 7, 2018

Bayer Codan Filter Recall: Loose Particulate Risk in IV Systems

Bayer recalls Codan Filter (BC 693) used with Medrad PAS and Intego PET Infusion systems due to potential loose particulate when dust cap is removed. Affected batch numbers listed in product description.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0097-2019Medical deviceBayer ›
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Recalling firmBayer Medical Care, Inc.1 Bayer Dr · Indianola, PA 15051-9702
✎ GovInfoNow plain-language explainer

Bayer is recalling Codan Filter (BC 693) used with Medrad Patient Administration Sets and Intego PET Infusion systems because testing found loose particulate may enter the fluid path when the dust cap is removed. This could potentially cause issues with IV treatments. Read more at govinfonow.com/recall/69899-bayer-codan-filter-recall-loose-particulate-risk-in-iv-systems.

Source Summary by GovInfoNow · govinfonow.com/recall/69899-bayer-codan-filter-recall-loose-particulate-risk-in-iv-systems · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0097-2019

Cite this page

“Bayer Codan Filter Recall: Loose Particulate Risk in IV Systems.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69899-bayer-codan-filter-recall-loose-particulate-risk-in-iv-systems. Based on FDA recall #Z-0097-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0097-2019%22&limit=1).

The FDA announced on Sept. 7, 2018, that Bayer Medical Care, Inc. is recalling Codan Filters (catalog number BC 693) due to loose particulate hazards. The agency stated the dust cap may generate particles that enter the fluid path.

How to tell if you have it

  • Codan Filter, catalog number BC 693
  • Used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems
  • 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

The hazard

Bayer has received reports of loose particulate in the filter when the dust cap is removed. Further testing confirmed the dust cap may generate particulate which may potentially enter the fluid path.

Context

GovInfoNow's records show Bayer Medical Care, Inc. has had 7 other recalls since June 28, 2018. Recent brand recalls include a July 31, 2026 sterilization issue with the Stellant FLEX Syringe Kit and an April 24, 2026 stopcock disengagement risk with Avanta Tube Sets. Other recent recalls of similar products include a March 24, 2026 Medline Medical Kits recall for particulate in fluid path risk and October 29, 2025 B Braun CARESAFE IV Sets recalls for medication backflow and occlusion risks.

How to tell if you have this one

Check for Codan Filter (BC 693) with batch numbers listed in the product description: 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.

  • Brand
    Bayer
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Filter Batch Number

    Identify the batch number on your Codan Filter (BC 693) to see if it matches the affected list: 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 it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 39 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 10 months after the firm started it.

1. Firm started the recall: Sep 7, 201812. FDA classified it Class II: Oct 11, 201823. Published in FDA’s Enforcement Report: Oct 17, 201834. FDA terminated the recall: Jul 11, 2019420182019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0097-2019 (September 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0097-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA