Product Wiki · Recalls · U.S. FDA — Device Enforcement

3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case — recall Z-0007-2024

U.S. FDA — Device Enforcement · United States · 2023-08-08 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0007-2024
Date of alert
2023-08-08
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Fresenius Medical Care Holdings, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
16945060500101
Reported risk: There is a potential for blood backfill leakage and foreign material.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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