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 Recall Z-0464-2014 · Posted 2013-12-06
Recalling FirmCenturion Medical Products Corporation
Recall StatusTerminated
Product CodeLDQ
Date Initiated2013-10-28
Date Terminated2014-01-29
Product Quantity500 lots
Reason for Recall
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.
Firm Action
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.
Root Cause
Labeling False and Misleading
Distribution Pattern
US Distribution including the states of GA, LA and NY.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.