Z-1616-2008

9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp...

Name: Z-1616-2008 9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp...
Creator: Cardiac Science Corporation
Published: 2008-01-23
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2008-01-23 / Terminated / root cause: manufacturing process

FDA source

Cardiac Science Corporation began a recall of 9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA 98021 on 2008-01-23. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1616-2008
Status: Terminated
Initiated: 2008-01-23
Posted: 2008-05-21
Terminated: 2011-07-21
Recalling firm: ZOLL Medical Corporation
Product: 9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA 98021.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: manufacturing process
FDA 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 in commerce: Lot W029275 - 24; Lot W029475 - 38
Distribution: Nationwide Distribution including states of CT, IA, IN, NC, NY, OH, PA, WA, and WI.
Product codes and lots: Lot Numbers: W029275 and W029476.

Product code MKJ

K971149Class IIISvl-9130 Defibrillation ElectrodeSurvivalink Corp. / cleared 1997-06-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)