Recall Z-0001-2014 ยท OFA Cardiovascular Surgical Instruments Tray
Maquet Cardiovascular, LLC
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 organ
| Date | Oct 1, 2013 (initiated Sep 20, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 20 units (Lot 25052176); 12 units (Lot #25052200) |
| Distribution | USA Nationwide Distribution in the states of: Florida, Maryland, New Jersey, New York and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.