10ML SYRINGE LUER LOCK W/OUT NEEDLE — Class I medical device recall Z-0005-2024
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2023-10-18, distributed nationwide. There is a potential for blood backfill leakage and foreign material.
| Recall number | Z-0005-2024 |
|---|---|
| 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 | 2023-08-08 |
| Classified | 2023-10-06 |
| Reported by FDA | 2023-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 124,773 boxes |
| Reason classes | foreign material, packaging |
| UPC / GTIN / UDI-DI | 16945060501122 |
| Model numbers | 100, 15-R010-0 |
Product
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Reason for recall
There is a potential for blood backfill leakage and foreign material.
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-0005-2024. 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.