Home / Recalls / Resource Optimization & Innovation Llc / Z-1553-2017

Z-1553-2017 Class II Terminated

Recalled by Resource Optimization & Innovation Llc — Springfield, MO

Recall Details

Product Type
Devices
Report Date
April 5, 2017
Initiation Date
January 9, 2017
Termination Date
September 28, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
420 kits

Product Description

Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hills

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.

Distribution Pattern

US Distribution to LA and TX.

Code Information

033493D Exp Date 2018-05-10; 035015D Exp Date 2018-07-12

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