Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for… — Class II medical device recall Z-1324-2016
Terminated recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2016-04-13, distributed nationwide. Dialyzer header leak due to possible improper torque
| Recall number | Z-1324-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA, United States |
| Recall initiated | 2016-02-26 |
| Classified | 2016-04-05 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2017-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,650 units |
| Reason classes | packaging |
| Lot numbers | 15KU04011 |
| Model numbers | 0520165A |
| Expiration dates | 2013-08-31 |
Product
Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
Reason for recall
Dialyzer header leak due to possible improper torque
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-1324-2016. 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.