FDA-Device2017-04-05Class II
Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
Resource Optimization & Innovation Llc
Hazard
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Sold states
US Distribution to LA and TX.
Affected count
274 kits
Manufactured in
2909 N Neergard Ave, Springfield, MO, United States
Products
Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1646-2017Don't want to check this manually?
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