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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 August 25, 2015
Date Posted October 30, 2015
Recall Status1 Terminated 3 on April 06, 2017
Recall Number Z-0187-2016
Recall Event ID 72052
510(K)Number K142080  
Product Classification Warmer, irrigation solution - Product Code LHC
Product Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
Code Information 22404, 23406, 23642, and 24032
Recalling Firm/
Manufacturer
Resource Optimization & Innovation Llc
2909 N Neergard Ave
Springfield MO 65803
For Additional Information Contact Robert W. Callahan
314-364-6561
Manufacturer Reason
for Recall
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
FDA Determined
Cause 2
Packaging
Action On August 25, 2015, the recalling firm sent an email to their direct customers informing them of the recall. The email instructed their customers to examine their inventory and determine whether they had any of the affected devices. The recalling firm attached the recall notice they received from their supplier. On September 4, 2015, the recalling firm sent a second email clarifying that they were instructing their customer to discard the supplier component . The notice also asked the customer to respond with how many affected devices they had in their inventory at the time they received the notice.
Quantity in Commerce 153 kits
Distribution Distributed in Texas and Louisiana.
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.
510(K) Database 510(K)s with Product Code = LHC and Original Applicant = ECOLAB, INC.
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