Codan Filter — Class II medical device recall Z-0097-2019
Terminated recall by Bayer Medical Care, Inc., reported 2018-10-17, distributed nationwide. Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted fu
| Recall number | Z-0097-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Medical Care, Inc., Indianola, PA, United States |
| Recall initiated | 2018-09-07 |
| Classified | 2018-10-11 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2019-07-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CL, CN, CR, CZ, DK, EE, EG, ES, FI, FR, GB, HR, HU, IL, IT, JO, KW, LB, LT, MA, MT, MX, NL, NO, OM, PA, PL, PT, RO, SA, SE, SG, SI, TH, TR |
| Reason classes | specification failure |
| Lot numbers | 14888, 17061, 20046, 20056, 70091, 72354, 72362, 72365, 72422, 72498, 72501, 72529, 72541, 72639, 72677, 72713, 72714, 72788, 72789, 72790, 72990, 73365, 73372, 73600, 73827, 73944, 74022, 74023, 74161, 74162, 74568, 74569, 74570, 74571, 74758, 75220, 75221, 75277, 75278, 75434 and 5 more |
| Model numbers | 693 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0097-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.