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U.S. Department of Health and Human Services

Class 2 Device Recall MEDRX Pediatric Feeding Tube

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 Class 2 Device Recall MEDRX Pediatric Feeding Tubesee related information
Date Initiated by FirmDecember 11, 2015
Create DateJanuary 06, 2016
Recall Status1 Terminated 3 on October 31, 2016
Recall NumberZ-0595-2016
Recall Event ID 72851
510(K)NumberK100700 
Product Classification Tube, feeding - Product Code FPD
ProductMED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada
Code Information Lots 114842, 116433 & 118251
FEI Number 3932
Recalling Firm/
Manufacturer		 Benlan, Inc.
2760 Brighton Road
Oakville Canada
For Additional Information ContactCheryl Brown
905-825-9300 Ext. 232
Manufacturer Reason
for Recall		The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.
FDA Determined
Cause 2		Under Investigation by firm
ActionBenlan, Inc. sent a Product Recall Notification letter dated December 11, 2015, to all affected customers. Customers were asked to examine their stock and to discontinue/use of the product and return product. The letter included a response form which was to be returned via fax to 905-825-9600. Customers with questions were instructed to call 905-825-9300.
Quantity in Commerce120 units
DistributionWorldwide Distribution - US including GA & Internationally to Canada.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = FPD
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