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U.S. Department of Health and Human Services

Class 2 Device Recall Ultima Activator II Reusable Drive Mechanism

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  Class 2 Device Recall Ultima Activator II Reusable Drive Mechanism see related information
Date Initiated by Firm February 09, 2022
Create Date April 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-0887-2022
Recall Event ID 89744
Product Classification Instruments, surgical, cardiovascular - Product Code DWS
Product Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Code Information UDI# 00607567700901, Lots (3): 25153700, 25157489, 25158616. Please note affected lot numbers (25153700, 25157489, 25158616) appear on the device package only. If the packaging has been discarded, the affected devices can be identified by Device Component Lot number (200501), which is etched onto all 3 device components on side of handle and on underside above each pin.
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
Manufacturer Reason
for Recall		 Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action On February 14, 2022, a customer notification letter was issued via FedEx. Customers are instructed to quarantine and return all affected product and notify all users within the hospital/facility. Please note affected lot numbers appear on the device package only. If the packaging has been discarded, the affected devices can be identified by Device Component Lot number, which is etched onto all 3 device components on side of handle and on underside above each pin. Customers are to complete and return the response form by email or fax. Distributors are to forward this document to customers for appropriate action. If you have any questions, please contact your Maquet Cardiovascular, LLC /Getinge representative or call the Getinge Customer Service at (888) 880-2874, Monday through Friday, between the hours of 6:00a.m. and 5:00 p.m. (Pacific Standard Time)
Quantity in Commerce 60
Distribution Worldwide - United States (AL, AZ, CA, FL, IL, KY, LA, MO, MT, NM, OH, PA, TX, WI), Germany, Republic of Korea (South Korea), Russia, Thailand, United Arab Emirates.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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