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Terminated

9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Cardiac Science Corp, Bothell, WA 98021.

FDA Recall Z-1616-2008 · Posted 2008-05-21

Recalling FirmCardiac Science Corporation
Recall StatusTerminated
Product CodeMKJ
Date Initiated2008-01-23
Date Terminated2011-07-21
Product QuantityLot W029275 - 24; Lot W029475 - 38

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution including states of CT, IA, IN, NC, NY, OH, PA, WA, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K971149SVL-9130 DEFIBRILLATION ELECTRODESurvivalink Corp. · 1997-06-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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