Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1423-04

Allegiance Laminated Crutch Accessories, item 74152-060, Allegiance Crutch Tips, 3/4'' x 1-7/8''; 24 tips per...

Duro-Med Industries, Inc. / initiated 2004-08-04 / Terminated / root cause: labeling and UDI

Duro-Med Industries, Inc. began a recall of Allegiance Laminated Crutch Accessories, item 74152-060, Allegiance Crutch Tips, 3/4'' x 1-7/8''; 24 tips per case; Distributed by Cardinal Health, McGaw Park... on . The reason FDA records is "The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1423-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Duro-Med Industries, Inc.
Product
Allegiance Laminated Crutch Accessories, item 74152-060, Allegiance Crutch Tips, 3/4'' x 1-7/8''; 24 tips per case; Distributed by Cardinal Health, McGaw Park, IL 60085-6787 USA, Made in China
Product code
INP Tips And Pads, Cane, Crutch And Walker
Reason for recall
The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches.
Root cause tag
labeling and UDI
FDA root cause
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
3 cases
Distribution
Nationwide distribution through Cardinal Health.
Product codes and lots
catalog #74152-060, all product labeled ''Made in China''