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U.S. Department of Health and Human Services

Class 2 Device Recall MAQUET Cardiovascular LLC AXIUS Blower Mister

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  Class 2 Device Recall MAQUET Cardiovascular LLC AXIUS Blower Mister see related information
Date Initiated by Firm January 24, 2019
Create Date March 07, 2019
Recall Status1 Terminated 3 on July 13, 2020
Recall Number Z-0983-2019
Recall Event ID 82090
510(K)Number K983135  
Product Classification Lavage, jet - Product Code FQH
Product AXIUS Blower Mister
Product Code/REF Number: CB-1000

The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
Code Information Lot Numbers: 96255605,96255607,96255608,96255609,96255611 UDI: 20607567700745
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
Manufacturer Reason
for Recall		 Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
FDA Determined
Cause 2		 Employee error
Action The firm, Maquet/Getinge, issued "URGENT MEDICAL DEVICE RECALL - REMOVAL" letters mailed to customers on January 24, 2019 via FedEx Priority Overnight,. The letters identified the issue, the product, actions to take and health risk. The customers were instructed to:Please examine your inventory immediately to determine if you have any of the affected; stop using the affected lot numbers of the Axius Blower Mister; remove and properly label any identified affected product, and keep it in quarantine in a secure location to preclude being used. Should you have un-used affected product you are eligible for either a replacement or credit. Please contact Geting Customer Service at 1-888-627-8383 (press option 2, then option 4) to request a return authorization (RMA) and shipping instructions to return any affected product. Complete and sign the MEDICAL DEVICE RECALL - REMOVAL RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to blowermister(@qetinge.com or by faxing the form to 1-800-915-0124. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at 1-888-627-8383 (press option 2, then option 4), Monday through Friday from 6:00 a.m. and 5:00 p.m. PST.
Quantity in Commerce 7,880 each (1,576 packs of 5)
Distribution Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, 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 = FQH and Original Applicant = CARDIOTHORACIC SYSTEMS, INC.
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