Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0805-05

LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction...

Laerdal Medical a/S / initiated 2005-04-29 / Terminated

Laerdal Medical Corporation began a recall of LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000... on . The reason FDA records is "Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0805-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Laerdal Medical a/S
Product
LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000 and 4000 series defibrillators and Philips Medical Systems CodeMaster 100 and XL series defibrillators. The Adapter Cable is supplied to customers as an independent accessory and is sold in a clear poly bag with a white stick on label that reads ''PART # 920650 ADAPTER CM100 / LMC ELECTRODE''. There is no other labeling and no directions for use that accompany the product. The Adapter Cable is also included as a component of the CodeMaster 100 Accessory Pack.
Product code
LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Reason for recall
Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator.
FDA root cause
Other
Action
Press release issued 4/28/2005. Letters to customers issued 4/29/2005. The letters sent via First Class Mail and are flagged: "URGENT RECALL NOTIFICATION". Customers instructed to order alternative electrode/cable solutions from Philips Medical Systems; discontinue clinical use of Adapter Cables; discard cables or use them for training purposes only.
Quantity in commerce
At least 3,019 units sold in the U.S.
Distribution
Nationwide and worldwide distribution. Laerdal Wappingers Falls, NY is only addressing the nationwide distribution. Laerdal Medical Corp. HQ in Norway is addressing worldwide distribution.
Product codes and lots
all lots