RS 5F DL BIOFLO PASV — Class II medical device recall Z-2214-2018
Terminated recall by Angiodynamics Inc. (Navilyst Medical Inc.), reported 2018-06-20, distributed in AZ, CA, CO, CT, DC, FL, GA, IL…. A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
| Recall number | Z-2214-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY, United States |
| Recall initiated | 2018-05-10 |
| Classified | 2018-06-14 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2020-05-13 |
| Distributed | AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, WV |
| Countries outside the US | CA, CN, ES, IE |
| Quantity | 104 boxes |
| Reason classes | microbial contamination, sterility |
| Lot numbers | 5301023, 5310193, 5312020 |
| Model numbers | 60M183481 |
Product
RS 5F DL BIOFLO PASV, Catalog Number 60M183481
Reason for recall
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
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-2214-2018. 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.