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Recall Observatory FDA recall evidence

Device 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

Z-0464-2014

October 28, 2013

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 66830
Status
Terminated
Classification
Class II
Quantity
500 lots
Official record key
device-enforcement:Z-0464-2014

Official wording

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.

Code information: EB84, Lot 2013041801 Expriation 2018/03

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.