Medical Device Recall: Z-0001-2014

FDA Recalls dataset · Firm: Maquet Cardiovascular, LLC · Status: Terminated

Recall Action Class: N/A Date Initiated: 2013-09-20 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0001-2014.

Recall Res Number
Z-0001-2014
Recalling Firm / Manufacturer
Maquet Cardiovascular, LLC
FEI Number
2242352
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2013-09-20
Date Posted
2013-10-01
Date Terminated
2014-06-10
Product Code
OFA
Event Number
66365
Product Quantity
20 units (Lot 25052176); 12 units (Lot #25052200)
Product Description 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.
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.
Action Details 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).
Distribution Pattern USA Nationwide Distribution in the states of: Florida, Maryland, New Jersey, New York and Texas.
Code Information / Serial Numbers ULTIMA OPCAB System Part Nos. OM-2003S (LOT #25052176) and OM-2001D (LOT #25052200).

Related Establishments / Registrations

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