Recall Z-0464-2014— Centurion Medical Products Corporation
Class II · Terminated
Class II FDA medical device recall by Centurion Medical Products Corporation, initiated 2013-10-28, terminated 2014-01-29. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..
- Recalling firm
- Centurion Medical Products Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-28
- Terminated
- 2014-01-29
- Firm location
- Howell, MI, United States
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.