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Terminated

Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.

FDA Recall Z-0578-03 · Posted 2003-02-26

Recalling FirmLifecor Inc
Recall StatusTerminated
Date Initiated2003-01-10
Date Terminated2003-07-30
Product Quantity174 units

Reason for Recall

Wires may break or pull out, causing device to malfunction

Firm Action

The recalling firm telephone the end/prescribed users and distributors. Follow up letters were issued to those that received phone calls. The end/prescribed users'' physicians were also notified via letter.

Root Cause

Other

Distribution Pattern

The device was shipped to distributors, hospitals, sales representatives. End users were prescribed by their physician. Distribution was to: CA, FL, GA, ID, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, UT and WA; and to Spain, Denmark, Italy, Turkey, Germany, United Kingdom, France and Belgium.

Official Source

View FDA Recall →

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

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