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

Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery. — recall Z-0184-2016

U.S. FDA — Device Enforcement · United States · 2015-08-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0184-2016
Date of alert
2015-08-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Resource Optimization & Innovation Llc
Product category
device
Product type
Devices
Reported risk: Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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