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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 25, 2015
Date Posted November 05, 2015
Recall Status1 Terminated 3 on April 06, 2017
Recall Number Z-0229-2016
Recall Event ID 72053
Product Classification General surgery tray (kit) - Product Code LRO
Product Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.
Code Information Lot 25787E, exp. date 1/19/2017
Recalling Firm/
Manufacturer		 Resource Optimization & Innovation Llc
2909 N Neergard Ave
Springfield MO 65803
For Additional Information Contact Wayne H. Flowers
417-820-2793
Manufacturer Reason
for Recall		 The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.
FDA Determined
Cause 2		 Component design/selection
Action ROi sent a Notice of Correction/Removal letter dated August 25, 2015, to all affected customers. The letter notified customers that ROi recently received notice of a voluntary recall from Edwards Lifesciences regarding their Transducer Kit. ROi also sent an email to their customer on September 25, 2015, informing them of the recall. Attached to the email was the component manufacturer's recall notice and a recall notice from the recalling firm. The recalling firm's recall notice instructed their customer to respond to the notice indicating whether they had any of the recalled product remaining and to destroy any remaining product in their inventory. For questions regarding this recall call 417-820-2793.
Quantity in Commerce 255 packs
Distribution Product was distributed to one customer in Oklahoma.
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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