Resource Optimization & Innovation Llc recalls Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU

Recall date

January 9, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1560-2017

FDA classification

Class II

Brand / firm

Resource Optimization & Innovation Llc

Sold / distributed

US Distribution to LA and TX.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU