Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac

FDA device recall Z-0001-2014 · posted 2013-10-01 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular, LLC

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 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).

Root cause

Error in labeling

Status

Terminated

Product code

OFA

Quantity affected

20 units (Lot 25052176); 12 units (Lot #25052200)

Distribution

USA Nationwide Distribution in the states of: Florida, Maryland, New Jersey, New York and Texas.

Date initiated

2013-09-20

Date posted

2013-10-01

Date terminated

2014-06-10

Location

Wayne, NJ