Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1415-04

ADP2.1 Adapter, non-sterile reusable Model Number: 30-802-1 ,an accessory used with the TissueLink BiPolar...

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

TissueLink Medical, Inc. began a recall of ADP2.1 Adapter, non-sterile reusable Model Number: 30-802-1 ,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-1415-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic Navigation, Inc
Product
ADP2.1 Adapter, non-sterile reusable Model Number: 30-802-1 ,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
164 units
Distribution
Nationwide
Product codes and lots
Lot Numbers: TLK113A0, TLL113A0, TLL29300, TLL293A0, TLL293B0, TLC18400