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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion Sterile 84 Rubber Bands

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 Class 2 Device Recall Centurion Sterile 84 Rubber Bandssee related information
Date Initiated by FirmOctober 28, 2013
Date PostedDecember 06, 2013
Recall Status1 Terminated 3 on January 29, 2014
Recall NumberZ-0464-2014
Recall Event ID 66830
Product Classification Device, general medical - Product Code LDQ
ProductCenturion 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
Code Information EB84, Lot 2013041801 Expriation 2018/03
FEI Number 1824619
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
301 Catrell Dr
Howell MI 48843-1703
For Additional Information ContactMatthew K. Price,
517-546-5400
Manufacturer 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.
FDA Determined
Cause 2		Labeling False and Misleading
ActionCenturion 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.
Quantity in Commerce500 lots
DistributionUS Distribution including the states of GA, LA and NY.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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