Home / Recalls / Resource Optimization & Innovation Llc / Z-1602-2017

Z-1602-2017 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: 40 kits

Product Description

Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels

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

033953B Exp Date 2018-06-02; 036773B Exp Date 2018-07-22

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Z-1657-2017 Class II — Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn (January 9, 2017)
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