FDA-Device2017-04-05Class II
Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Santa Rosa
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
280 kits
Manufactured in
2909 N Neergard Ave, Springfield, MO, United States
Products
Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Santa Rosa
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1624-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief