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U.S. Department of Health and Human Services

Class 2 Device Recall Allegiance Laminated Wood Crutches, Large Adult

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  Class 2 Device Recall Allegiance Laminated Wood Crutches, Large Adult see related information
Date Initiated by Firm August 04, 2004
Date Posted September 01, 2004
Recall Status1 Terminated 3 on March 24, 2006
Recall Number Z-1417-04
Recall Event ID 29753
Product Classification Crutch - Product Code IPR
Product Allegiance Laminated Wood Crutches, item 74151-010, Large Adult - 51'' - 64''; 1 pair individually shrink wrapped, 10 pairs per case; Distributed by Cardinal Health, McGaw Park, IL 60085-6787 USA, Made in China
Code Information catalog #74151-010, 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 202 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.
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