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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 Regardsee related information
Date Initiated by FirmJanuary 09, 2017
Create DateMarch 24, 2017
Recall Status1 Terminated 3 on September 28, 2018
Recall NumberZ-1545-2017
Recall Event ID 76255
Product Classification General surgery tray - Product Code LRO
ProductRegard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels
Code Information 029663A Exp Date: 2017-10-30; 031173A Exp Date 2018-01-25; 032155A Exp Date: 2018-02-28;
Recalling Firm/
Manufacturer		 Resource Optimization & Innovation Llc
2909 N Neergard Ave
Springfield MO 65803-6317
For Additional Information ContactDebbie Seilling-Ferguson
417-820-2793
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
ActionROi 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 Commerce46 kits
DistributionUS Distribution to LA and TX.
Total Product Life CycleTPLC 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.
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