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Terminated

Allegiance Laminated Wood Crutches, item 74151-040, Youth - 35'' - 43''; 1 pair individually shrink wrapped, 10 pairs per case; Distributed by Cardinal Health, McGaw Park, IL 60085-6787 USA, Made in China

FDA Recall Z-1420-04 · Posted 2004-09-01

Recalling FirmDuro-Med Industries, Inc.
Recall StatusTerminated
Product CodeIPR
Date Initiated2004-08-04
Date Terminated2006-03-24
Product Quantity230 cases

Reason for Recall

The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide distribution through Cardinal Health.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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