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

Recall Z-1194-2013 — A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit

U.S. FDA — Device Enforcement · United States · 2013-03-26 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1194-2013
Date of alert
2013-03-26
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Cardinal Health, Medical Products & Services
Product category
device
Product type
Devices
Reported risk: Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
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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