Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0543-2007

Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4'' connector, arterial cannula...

Terumo Cardiovascular Systems Corporation / initiated 2006-12-07 / Terminated

Terumo Cardiovascular Systems Corp began a recall of Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4'' connector, arterial cannula, 10 FR, 17.5 cm (7'') long; Catalog no. L7350 on . The reason FDA records is "The cannula connector is an incorrect size: It is actually 1/4" by 3/8" instead of the correct 1/4" by 1/4"". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0543-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Terumo Cardiovascular Systems Corporation
Product
Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4'' connector, arterial cannula, 10 FR, 17.5 cm (7'') long; Catalog no. L7350.
Product code
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall
The cannula connector is an incorrect size: It is actually 1/4" by 3/8" instead of the correct 1/4" by 1/4".
FDA root cause
Other
Action
Consignee was notified via telephone on 12/7/06 and returned the product.
Quantity in commerce
50
Distribution
Pennsylvania.
Product codes and lots
Lot 2119436, exp. October 2009.