Date Initiated by Firm | December 15, 2003 |
Date Posted | January 14, 2004 |
Recall Status1 |
Terminated 3 on September 13, 2008 |
Recall Number | Z-0344-04 |
Recall Event ID |
27910 |
Product Classification |
Wheelchair, Powered - Product Code ITI
|
Product | Invacare 2G Tarsys Seating System, Model 2GTR. |
Code Information |
Serial Numbers: 00Axxx thru 00Lxxx, 01Axxx thru 01Lxxx, and 02Axxx. |
Recalling Firm/ Manufacturer |
Invacare Corporation 1200 Taylor St Elyria OH 44035-6248
|
For Additional Information Contact | Ms. Janice Brownlee 440-329-6595 |
Manufacturer Reason for Recall | The weld joints on the seat back may fail and cause possible injury to the patient. |
FDA Determined Cause 2 | Other |
Action | The firm notified their consignees by letter and telephone on 12/15/2003. |
Quantity in Commerce | 5,990 units |
Distribution | The units were shipped to domestic dealerships located nationwide, and to foreign accounts in Canada, China, Oman, and West Indies. |
Total Product Life Cycle | TPLC Device Report |
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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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