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

Recall Z-0141-2024 — Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

U.S. FDA — Device Enforcement · United States · 2023-09-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0141-2024
Date of alert
2023-09-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smiths Medical ASD Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
30351688028635
Reported risk: The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and Lot# 4331283. Tubes without caps have the potential to generate delayed or erroneous test results and/or exposure to infectious blood.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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