9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA 98021.
This recall has been terminated (originally issued May 21, 2008).
- Company
- Cardiac Science Corporation
- Recall Initiated
- January 23, 2008
- Posted
- May 21, 2008
- Terminated
- July 21, 2011
- Recall Number
- Z-1616-2008
- Quantity
- Lot W029275 - 24; Lot W029475 - 38
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Adaptor Cable Incorrectly Manufactured: The red and white connector ends of the adapter are switched. Therefore, the cable will not connect to the electrodes as indicated in the instructions.
Distribution
Nationwide Distribution including states of CT, IA, IN, NC, NY, OH, PA, WA, and WI.
Lot / Code Info
Lot Numbers: W029275 and W029476.
Root Cause
Process control
Action Taken
Consignees were notified by an Urgent Medical Device Recall letter sent on 01/23/2008. The letter instructs users to check each cable of the affected lot to ensure that it properly connects to the electrode. Users were also instructed to return any defective product to the recalling firm for a replacement. For additional information, contact 1-888-466-8686 x2041.