QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series.
This recall has been terminated (originally issued November 2, 2005).
- Recall Initiated
- September 2, 2005
- Posted
- November 2, 2005
- Terminated
- January 17, 2011
- Recall Number
- Z-0116-06
- Quantity
- total for both types - 52,654
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for voltage pins in connector of therapy cable to break.
Distribution
Devices were distributed worldwide.
Lot / Code Info
Cables do not contain serial numbers. Therapy cable part number: 3006570-006 and below
Root Cause
Other
Action Taken
On 9/2/05 the firm issued letters dated September 2005 to their customers. The letters state the problem, advise the cables and/or connectors will be replaced, and emphasize daily inspection and testing,
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