Z-0007-2024 Class I Ongoing
FDA device recall Z-0007-2024 was initiated by Fresenius Medical Care Holdings, Inc. on August 8, 2023 and is designated Class I. Reason for recall: There is a potential for blood backfill leakage and foreign material. The recall status is ongoing. Affected quantity: 124,773 boxes total.
Recall Details
- Product Type
- Devices
- Report Date
- October 18, 2023
- Initiation Date
- August 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 124,773 boxes total
Product Description
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Reason for Recall
There is a potential for blood backfill leakage and foreign material.
Distribution Pattern
US Nationwide.
Code Information
UDI-DI: 16945060500101; All Lots