LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator p
FDA device recall Z-0805-05 · posted 2005-05-12 · Terminated
Recall details
- Recalling firm
- Laerdal Medical Corporation
- Reason for recall
- Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LDD
- Quantity affected
- 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.
- Date initiated
- 2005-04-29
- Date posted
- 2005-05-12
- Date terminated
- 2008-01-18
- Location
- Wappingers Falls, NY
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