FDA Enforcement
Class I
Ongoing
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Recall: Z-0007-2024
·
Reported October 18, 2023
Enforcement
- Recall Number
- Z-0007-2024
- Event ID
- 92906
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Fresenius Medical Care Holdings, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 18, 2023
- Initiation Date
- August 8, 2023
- Classification Date
- October 6, 2023
- Address
- 920 Winter St Bld 920, N/A, Waltham, MA, 02451-1521, United States
Description
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Reason
There is a potential for blood backfill leakage and foreign material.
Code Info
UDI-DI: 16945060500101; All Lots
Distribution
US Nationwide.
Quantity
124,773 boxes total