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

Recall Z-1115-2022 — Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE

U.S. FDA — Device Enforcement · Denmark · 2022-04-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1115-2022
Date of alert
2022-04-08
Country / jurisdiction
Denmark
Risk level
Class II
Risk type
recall
Brand
Radiometer Medical ApS
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05700699565525
Reported risk: Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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