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Resource Optimization & Innovation Llc recalls Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn
Recalled April 5, 2017 · FDA recall Z-1585-2017 · Resource Optimization & Innovation
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. · FDA Class II
Units
36 kits
Sold at
US Distribution to LA and TX.
Description
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.
Product
Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn
Manufacturer(s)
Resource Optimization & Innovation Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →