Recall Z-1644-2017— Resource Optimization & Innovation Llc

Name: FDA recall Z-1644-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-09

Class II · Terminated

Class II FDA medical device recall by Resource Optimization & Innovation Llc, initiated 2017-01-09, terminated 2018-09-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn. Reason: 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..

Recalling firm: Resource Optimization & Innovation Llc
Classification: Class II
Status: Terminated
Initiated: 2017-01-09
Terminated: 2018-09-28
Firm location: Springfield, MO, United States

Product description

Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.