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U.S. Department of Health and Human Services

Class 2 Device Recall Regard

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  Class 2 Device Recall Regard see related information
Date Initiated by Firm January 09, 2017
Create Date March 24, 2017
Recall Status1 Terminated 3 on September 28, 2018
Recall Number Z-1560-2017
Recall Event ID 76255
Product Classification General surgery tray - Product Code LRO
Product Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU
Code Information 037321B Exp Date 2018-08-12
Recalling Firm/
Resource Optimization & Innovation Llc
2909 N Neergard Ave
Springfield MO 65803-6317
For Additional Information Contact Debbie Seilling-Ferguson
Manufacturer 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.
FDA Determined
Cause 2
Nonconforming Material/Component
Action ROi sent an Urgent Recall Notice dated January 9, 2017, to all affected consignees. The recalling firm instructed consignees to quarantine affected product and complete the response form. The recalling firm stated that they will issue over lableing for the affected packs. Sterile replacement light covers will be sent directly to the end user if available. Consignees were instructed to inform their subaccounts of the recall. For questions regarding this recall call 417-820-2793.
Quantity in Commerce 30 kits
Distribution US Distribution to LA and TX.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.