Recall Z-1417-04 ยท IPR Crutch
Duro-Med Industries, Inc.
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
| Date | Sep 1, 2004 (initiated Aug 4, 2004) |
| Status | Terminated |
| Reason | The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches. |
| 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 | 202 cases |
| Distribution | Nationwide distribution through Cardinal Health. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.