FDA-Device2015-11-04Class II
Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.
Resource Optimization & Innovation Llc
Hazard
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Sold states
Distributed in Texas and Louisiana.
Affected count
57 kits
Manufactured in
2909 N Neergard Ave, N/A, Springfield, MO, United States
Products
Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0188-2016Don't want to check this manually?
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