Z-1576-2017 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
248 kits

Product Description

Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU

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

027338B Exp Date 2017-05-30; 027664B Exp Date 2017-06-30; 028391B Exp Date 2017-07-30; 028752B Exp Date 2017-07-30; 029416B Exp Date 2017-09-30; 030580B Exp Date 2017-10-30; 032134B Exp Date 2018-01-30;