Date Initiated by Firm | August 25, 2015 |
Date Posted | October 30, 2015 |
Recall Status1 |
Terminated 3 on April 06, 2017 |
Recall Number | Z-0186-2016 |
Recall Event ID |
72052 |
510(K)Number | K142080 |
Product Classification |
Warmer, irrigation solution - Product Code LHC
|
Product | Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery. |
Code Information |
24641 |
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 | 77 kits |
Distribution | Distributed in Texas and Louisiana. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = LHC
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