—#123693

Product

Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. LATEX FREE , CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Single Use Only bands items together and podiatry office uses bands as tourniquet on toe during in grown toenail procedure

FDA product code: LDQ
Affected lot / code info: EB84, Lot 2013041801 Expriation 2018/03

Why it was recalled

Package labeling indicates both "latex free" and "contains natural rubber latex" . The rubber bands do contain natural rubber latex. This could cause a significant risk to users with latex allergies.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

Centurion sent a Urgent Recall Notification letter via Certified Mail October 31, 2013, return receipt to all affected customers. The affected Centurion Medical Products Corporation sales representatives were notified via email on October 28, 2013. Customers were instructed to destroy all implicated product and complete the accountability record included with the notice and fax to 517-546-3356. Customers were asked to forward a copy of the notice if product was further distributed. Additional notices will be mailed to non-responsive customers via Certified Mail Return Receipt, and will be documented in the recall file. For further questions please call (517) 546-5400.

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 301 Catrell Dr, Howell, Michigan 48843-1703

Distribution

Distribution pattern: US Distribution including the states of GA, LA and NY.

Timeline

Recall initiated: 2013-10-28
Posted by FDA: 2013-12-06
Terminated: 2014-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #123693. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.