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U.S. Department of Health and Human Services

Class 1 Device Recall

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 Class 1 Device Recallsee related information
Date Initiated by FirmApril 29, 2005
Date PostedMay 12, 2005
Recall Status1 Terminated 3 on January 18, 2008
Recall NumberZ-0805-05
Recall Event ID 31571
Product Classification Dc-Defibrillator, Low-Energy, (Including Paddles) - Product Code LDD
ProductLAERDAL 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.
Code Information all lots
FEI Number 2425852
Recalling Firm/
Manufacturer		 Laerdal Medical Corporation
167 Myers Corner Rd
PO Box 1840
Wappingers Falls NY 12590-8840
For Additional Information Contact
800-668-4391
Manufacturer Reason
for Recall		Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator.
FDA Determined
Cause 2		Other
ActionPress 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 CommerceAt least 3,019 units sold in the U.S.
DistributionNationwide and worldwide distribution. Laerdal Wappingers Falls, NY is only addressing the nationwide distribution. Laerdal Medical Corp. HQ in Norway is addressing worldwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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