Recall Z-1616-2008
Cardiac Science Corporation · initiated January 23, 2008
Product
9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA 98021.
Codes / lots: Lot Numbers: W029275 and W029476.
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.
FDA-determined 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.
Details
- Recall number
- Z-1616-2008
- Initiated
- January 23, 2008
- Posted by FDA
- May 21, 2008
- Terminated
- July 21, 2011
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- Lot W029275 - 24; Lot W029475 - 38
- Distribution
- Nationwide Distribution including states of CT, IA, IN, NC, NY, OH, PA, WA, and WI.
- Recalling firm
- Cardiac Science Corporation, Bothell, WA