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U.S. Department of Health and Human Services

Class 2 Device Recall MEDRX POLYURETHANE FEEDING TUBE

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  Class 2 Device Recall MEDRX POLYURETHANE FEEDING TUBE see related information
Date Initiated by Firm December 01, 2018
Create Date January 11, 2019
Recall Status1 Open3, Classified
Recall Number Z-0725-2019
Recall Event ID 81763
510(K)Number K100700  
Product Classification Tube, feeding - Product Code FPD
Product MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R

Product Usage:
A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician.
Code Information Lot 139457
Recalling Firm/
Manufacturer
Canadian Hospital Specialties
2760 Brighton Rd
Oakville Canada
For Additional Information Contact
905-825-9300
Manufacturer Reason
for Recall
The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm notified its consignees of the recall by email on 12/01/2018. The letter identified the affected product, problem and actions to be taken. The firm requested return of the product.
Quantity in Commerce 75 cases of 10
Distribution US in the states of TN
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FPD and Original Applicant = BENLAN, INC.
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