Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.
This recall has been terminated (originally issued February 26, 2003).
- Company
- Lifecor Inc
- Recall Initiated
- January 10, 2003
- Posted
- February 26, 2003
- Terminated
- July 30, 2003
- Recall Number
- Z-0578-03
- Quantity
- 174 units
- Firm Location
- Pittsburgh, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Wires may break or pull out, causing device to malfunction
Distribution
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.
Lot / Code Info
Product No 10A0889-A01
Root Cause
Other
Action Taken
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.