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U.S. Department of Health and Human Services

Class 2 Device Recall Regard Custom Surgical Pack

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  Class 2 Device Recall Regard Custom Surgical Pack see related information
Date Initiated by Firm August 19, 2015
Date Posted September 21, 2015
Recall Status1 Terminated 3 on April 05, 2017
Recall Number Z-2799-2015
Recall Event ID 72008
Product Classification General surgery tray (kit) - Product Code LRO
Product Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.
Code Information 025072B
Recalling Firm/
Manufacturer		 Resource Optimization & Innovation Llc
2909 N Neergard Ave
Springfield MO 65803
For Additional Information Contact Robert W. Callahan
314-364-6461
Manufacturer Reason
for Recall		 Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
FDA Determined
Cause 2		 Material/Component Contamination
Action On 8/19/2015, the recalling firm sent its two consignees an email with the recall notice attached. The notice notified their customers that they were affected by the recalling firm's supplier's recall. The notice instructed the customers to dispose of the recalled component and acknowledge receipt of the recall notice.
Quantity in Commerce 67 kits
Distribution Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.
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.
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