Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1416-04

ADP 3.2 Adapter, non sterile reusable Model Number: 30-801-1, an accessory used with the TissueLink Bipolar...

Medtronic Navigation, Inc / initiated 2004-07-22 / Terminated

TissueLink Medical, Inc. began a recall of ADP 3.2 Adapter, non sterile reusable Model Number: 30-801-1, an accessory used with the TissueLink Bipolar Floating Device on . The reason FDA records is "Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1416-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic Navigation, Inc
Product
ADP 3.2 Adapter, non sterile reusable Model Number: 30-801-1, an accessory used with the TissueLink Bipolar Floating Device
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall
Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing.
FDA root cause
Other
Action
TissueLink notified the sales force on 7/22/04 to visit each account and retreive product at the hospital level.
Quantity in commerce
96 units
Distribution
Nationwide
Product codes and lots
Lot Numbers: TLK17300, TLB02400