stay-safe /Safe Lock Catheter Ext — Class I medical device recall Z-1323-2024
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2024-04-03, distributed nationwide. The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
| Recall number | Z-1323-2024 |
|---|---|
| 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 | 2024-01-23 |
| Classified | 2024-03-26 |
| Reported by FDA | 2024-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 114,982 eaches |
| UPC / GTIN / UDI-DI | 00840861100767, 10840861100764 |
| Model numbers | 050-95001 |
Product
stay-safe /Safe Lock Catheter Ext. 12 in
Reason for recall
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
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-1323-2024. 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.