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U.S. Department of Health and Human Services

Class 2 Device Recall Medical Tubing with Cortiva BioActive Surface.

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 Class 2 Device Recall Medical Tubing with Cortiva BioActive Surface.see related information
Date Initiated by FirmAugust 08, 2018
Create DateJuly 04, 2020
Recall Status1 Terminated 3 on October 06, 2020
Recall NumberZ-2495-2020
Recall Event ID 85821
510(K)NumberK891687 
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
ProductExtra corporeal circuit with bio-active surface.
Code Information Lot# 215729283
FEI Number 1000116158
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information ContactJoey Lomicky
763-526-2494
Manufacturer Reason
for Recall		Affected products failed a sterilization test.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn August 8th Medtronic vervally communicated to the consignees to informed them about the situation and affected product. On August 20th they send a letter to the consignees stating that "as a result of the immediate verbal communication, your Medtronic representative has already retrieved the affected product from your facility. This notification is for your awareness and Medtronic requests that you complete and return the attached Customer Confirmation Certificate to RS.CFQFCA@Medtronic.com."
Quantity in Commerce10 units
DistributionDomestic Distribution only to CA and MI.
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.
510(K) Database510(K)s with Product Code = DTZ
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