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Class 2 Device Recall Life Vest WCD 3000 Electrode Belt |
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| Date Initiated by Firm |
January 10, 2003 |
| Date Posted |
February 26, 2003 |
| Recall Status1 |
Terminated 3 on July 30, 2003 |
| Recall Number |
Z-0578-03 |
| Recall Event ID |
25387 |
| PMA Number |
P010030 |
| Product |
Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI. |
| Code Information |
Product No 10A0889-A01 |
Recalling Firm/
Manufacturer |
Lifecor Inc
121 Freeport Rd
Pittsburgh PA 152383447
|
| For Additional Information Contact |
Gene Partin
412-826-9300
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Manufacturer Reason
for Recall |
Wires may break or pull out, causing device to malfunction
|
FDA Determined
Cause 2 |
Other |
| 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. |
| Quantity in Commerce |
174 units |
| 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. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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