FDA Recall
Terminated
Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.
Recall: Z-0578-03
·
Initiated January 10, 2003
Recall
- Recall Number
- Z-0578-03
- Event Number
- 25387
- Firm
- Lifecor Inc
- FEI Number
- 3008642652
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 10, 2003
- Posted
- February 26, 2003
- Terminated
- July 30, 2003
- Address
- 121 Freeport Rd, Pittsburgh, PA, 152383447
Description
Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.
Reason
Wires may break or pull out, causing device to malfunction
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.
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.
Quantity
174 units