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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 TUBEsee related information
Date Initiated by FirmDecember 01, 2018
Create DateJanuary 11, 2019
Recall Status1 Terminated 3 on April 02, 2021
Recall NumberZ-0725-2019
Recall Event ID 81763
510(K)NumberK100700 
Product Classification Tube, feeding - Product Code FPD
ProductMED-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
FEI Number 3932
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
ActionThe 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 Commerce75 cases of 10
DistributionUS in the states of TN
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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