Date Initiated by Firm |
January 27, 2013 |
Date Posted |
June 21, 2013 |
Recall Status1 |
Terminated 3 on July 18, 2018 |
Recall Number |
Z-1578-2013 |
Recall Event ID |
65193 |
Product Classification |
Lift, patient, ac-powered - Product Code FNG
|
Product |
Prism Medical C-Series Carry Bar, Class I, model number 360755.
The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients. |
Code Information |
model number 360755 |
Recalling Firm/ Manufacturer |
Prism Medical Services USA 45 Progress Pkwy Maryland Heights MO 63043-3701
|
For Additional Information Contact |
Agustin Garcia de Paredes, P. Eng 905-850-9003 Ext. 249
|
Manufacturer Reason for Recall |
The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars.
|
FDA Determined Cause 2 |
Use error |
Action |
The firm, Prism Medical, sent a letter dated January 27, 2013 to is customers.The letter described the product, problem and actions to be taken. The customers were instructed to perform an immediate safety check checking that both the pin and the plug have been inserted into the carry bar as outlined in the attached User Instruction guide. Prism offered to replace the recalled product with a different product with greater functionality.
If you have any questions, contact VP-Global Product Development at 416-726-3107. |
Quantity in Commerce |
1131 carry bars/New England |
Distribution |
Worldwide distribution: US (nationwide) and country of: Canada. |
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|