Recall Z-0001-2014
Maquet Cardiovascular, LLC · initiated September 20, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: ULTIMA OPCAB System Part Nos. OM-2003S (LOT #25052176) and OM-2001D (LOT #25052200).
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: Error in labeling
Action taken
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).
Details
- Recall number
- Z-0001-2014
- Initiated
- September 20, 2013
- Posted by FDA
- October 1, 2013
- Terminated
- June 10, 2014
- Product code
- OFA – Cardiovascular Surgical Instruments Tray
- Quantity
- 20 units (Lot 25052176); 12 units (Lot #25052200)
- Distribution
- USA Nationwide Distribution in the states of: Florida, Maryland, New Jersey, New York and Texas.
- Recalling firm
- Maquet Cardiovascular, LLC, Wayne, NJ