PlainRecalls
FDA Devices Critical Class I Ongoing

3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case

Reported: October 18, 2023 Initiated: August 8, 2023 #Z-0007-2024

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.

Details

Units Affected
124,773 boxes total
Distribution
US Nationwide.
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 124,773 boxes total.
Why was this product recalled?
There is a potential for blood backfill leakage and foreign material.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 18, 2023. Severity: Critical. Recall number: Z-0007-2024.