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U.S. Department of Health and Human Services

Class 2 Device Recall ULTIMA OPCAB System

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 Class 2 Recall
ULTIMA OPCAB System
see related information
Date Posted October 01, 2013
Recall Status1 Terminated on June 10, 2014
Recall Number Z-0001-2014
Recall Event ID 66365
Product Classification Cardiovascular Surgical Instruments Tray (Kit) - Product Code OFA
Product Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stablizer isolates and provides local immobilization of the target vessel on the beating heart.
Code Information ULTIMA OPCAB System Part Nos. OM-2003S (LOT #25052176) and OM-2001D (LOT #25052200).
Recalling Firm/
Manufacturer
Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne, New Jersey 07470-2094
For Additional Information Contact Mr. Mark Dinger
973-709-7691
Manufacturer Reason
for Recall
MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for the 2 blade lots had been incorrectly applied. The standard blades from Lot #25052176 were incorrectly labeled as deep blades, and the 20 deep blades from Lot #25052200 were incorrectly labeled as standard blades.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action MAQUET sent an "Urgent Medical Device Recall" letter and "Field Recall Response Forms" dated September 20, 2013 to customers via Federal Express. The notification identifies the affected product; informs the customers of the nature of the issue; and advises of potential adverse patient consequences that may occur. The customer is asked to complete and return the Field Recall Response Form. If the customer has questions they are directed to contact their field representative or MAQUET Technical Support (888.627.8383 between 8 am and 5 pm EST Monday through Friday).
Quantity in Commerce 20 units (Lot 25052176); 12 units (Lot #25052200)
Distribution USA Nationwide Distribution in the states of: Florida, Maryland, New Jersey, New York and Texas.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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