2008T GEN 2 Bibag without CDX — Class I medical device recall Z-0031-2024
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2023-10-18, distributed nationwide. Potential PCBA leaching from tubing of hemodialysis machines.
| Recall number | Z-0031-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2023-09-06 |
| Classified | 2023-10-06 |
| Reported by FDA | 2023-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 733 units |
| UPC / GTIN / UDI-DI | 00840861100927 |
| Serial numbers | 0T0S248136, 0T0S248148, 0T0S248150, 0T0S248156, 0T0S251261, 0T0S251286, 0T0S251309, 0T0S251319, 0T0S251792, 0T0S251809, 0T0S251810, 0T0S251811, 1T0S260311, 1T0S260346, 1T0S260349, 1T0S260352, 1T0S260358, 1T0S260367, 1T0S260370, 1T0S260374, 1T0S260397, 1T0S260405, 1T0S260419, 1T0S260423, 1T0S260424 and 182 more |
| Model numbers | 190895 |
Product
2008T GEN 2 Bibag without CDX
Reason for recall
Potential PCBA leaching from tubing of hemodialysis machines.
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-0031-2024. 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.