FDA Device recall Z-0005-2024
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
- FDA Device
- Class I
- ongoing
- Published 2023-10-18
On 2023-10-18 the FDA classified a Class I recall of 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case by Fresenius Medical Care Holdings, citing there is a potential for blood backfill leakage and foreign material.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0005-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-08-08 |
| Published | 2023-10-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Reason
There is a potential for blood backfill leakage and foreign material.
Identifiers
| code_info | UDI-DI: 16945060501122; All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0005-2024%22
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