Date Initiated by Firm | August 04, 2004 |
Date Posted | September 01, 2004 |
Recall Status1 |
Terminated 3 on March 24, 2006 |
Recall Number | Z-1422-04 |
Recall Event ID |
29753 |
Product Classification |
Tips And Pads, Cane, Crutch And Walker - Product Code INP
|
Product | Allegiance Laminated Crutch Accessories, item 74152-010, Allegiance Crutch Underarm Pad; 2 pads per package, 12 packages per case; Distributed by Cardinal Health, McGaw Park, IL 60085-6787 USA, Made in China |
Code Information |
catalog #74152-010, all product labeled ''Made in China'' |
Recalling Firm/ Manufacturer |
Duro-Med Industries, Inc. 1788 W Cherry St P. O. Box 547 Jesup GA 31545-0629
|
For Additional Information Contact | Mr. Andrew P. Kapinos 847-680-6811 |
Manufacturer Reason for Recall | The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches. |
FDA Determined Cause 2 | Other |
Action | Duro-Med notified Cardinal Health of the recall by letter dated 8/4/04. Cardinal Health initiated a sub-recall of the products by letter dated 8/18/04. The accounts were informed that the products made in China contain latex, and were requested to check their inventories for the affected products and return those products found to be labeled as 'Made in China' for credit. Questions were directed to Cardinal Quality Systems at 1-800-292-9332. |
Quantity in Commerce | 6 cases |
Distribution | Nationwide distribution through Cardinal Health. |
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.
|