9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA
FDA device recall Z-1616-2008 · posted 2008-05-21 · Terminated
Recall details
- Recalling firm
- Cardiac Science Corporation
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- Lot W029275 - 24; Lot W029475 - 38
- Distribution
- Nationwide Distribution including states of CT, IA, IN, NC, NY, OH, PA, WA, and WI.
- Date initiated
- 2008-01-23
- Date posted
- 2008-05-21
- Date terminated
- 2011-07-21
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SVL-9130 DEFIBRILLATION ELECTRODE (K971149) | Survivalink Corp. | 1997-06-23 |