FDA Medical Device Recalls (openFDA)
Cardiac Science Corporation: 9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA 98021.
- Recall number
- Z-1616-2008
- Recalling firm
- Cardiac Science Corporation
- Product
- 9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA 98021.
- Status
- Terminated
- Initiated
- 2008-01-23
- Posted
- 2008-05-21
- Terminated
- 2011-07-21
- 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.
- Lot, serial or model codes
- Lot Numbers: W029275 and W029476.
- 510(k) numbers
- ["K971149"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 2112020
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28