FDA-Device2015-11-04Class II
Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
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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
77 kits
Manufactured in
2909 N Neergard Ave, N/A, Springfield, MO, United States
Products
Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0186-2016Don't want to check this manually?
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