FDA-Device2023-10-18Class I

10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Fresenius Medical Care Holdings, Inc.
Hazard

There is a potential for blood backfill leakage and foreign material.

Sold states
US Nationwide.
Affected count
124,773 boxes total
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Products
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0006-2024

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