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U.S. Department of Health and Human Services

Class 2 Device Recall Aortic Arterial Cannula

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  Class 2 Device Recall Aortic Arterial Cannula see related information
Date Initiated by Firm May 14, 2018
Create Date June 11, 2018
Recall Status1 Terminated 3 on May 15, 2020
Recall Number Z-2159-2018
Recall Event ID 80076
510(K)Number K012774  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass
Code Information UDI CODE: 04037691085555, Lot Number: 92196585
Recalling Firm/
Manufacturer
Maquet Cardiopulmonary Ag
Kehler Strasse 31
Rastatt Germany
Manufacturer Reason
for Recall
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
FDA Determined
Cause 2
Component design/selection
Action Urgent Medical Device Recall letters were distributed beginning 5/14/18. The letters instructed customers to do the following: 1. Read and understand this notification, and disseminate the information provided to all users, or prospective users, of the affected arterial cannulae. 2. Check your arterial cannula inventory and compare with the Getinge part number, article number and lot number provided on Page 1 of this notification. 3. Remove any affected product that are still in your inventory and prepare it for shipment back to Getinge. 4. Call Getinge Customer Support at 1-888-627-8383 (Press Option 2 and then Option 2) for a Return Authorization (RGA) and for shipping information and label. Customer Support will issue a credit for the product return. 5. Complete, sign and promptly return the filled out response form (Page 4 of this notification) either by email to FieldActions@getinge.com or by fax to 1-973-860-1675.
Quantity in Commerce 40 US
Distribution Worldwide distribution including US state of VA and Puerto Rico, Australia, Belgium, Brazil, Canada, Chile, Colombia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Martinique, Mauritius, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, and United Kingdom.
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 = DWF and Original Applicant = JOSTRA AG
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