FDA recall Z-0007-2024
Fresenius Medical Care Holdings, Inc. · Class I · device
Product
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
US Nationwide.
Key facts
- Status
- Ongoing
- Initiation date
- 2023-08-08
- Report date
- 2023-10-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waltham, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0007-2024