Recall Z-1616-2008 ยท MKJ Automated External Defibrillators (Non-Wearable)
Cardiac Science Corporation
9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA 98021.
| Date | May 21, 2008 (initiated Jan 23, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | Lot W029275 - 24; Lot W029475 - 38 |
| Distribution | Nationwide Distribution including states of CT, IA, IN, NC, NY, OH, PA, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971149 | SVL-9130 DEFIBRILLATION ELECTRODE Survivalink Corp., Jun 23, 1997 |