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U.S. Department of Health and Human Services

Class 2 Device Recall MEDRX Polyurethane Feeding Tube For Pediatric Use

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 Class 2 Device Recall MEDRX Polyurethane Feeding Tube For Pediatric Usesee related information
Date Initiated by FirmJune 11, 2018
Date PostedJuly 13, 2018
Recall Status1 Terminated 3 on March 13, 2019
Recall NumberZ-2440-2018
Recall Event ID 80374
510(K)NumberK100700 
Product Classification Tube, feeding - Product Code FPD
ProductMED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 10/case, Sterile, RX. The firm name on the label is chs, Oakville, ON, Canada.
Code Information Lot #135137
FEI Number 3932
Recalling Firm/
Manufacturer		 Canadian Hospital Specialties
2760 Brighton Rd
Oakville Canada
Manufacturer Reason
for Recall		The product may be packaged with the incorrect length of feeding tube as labeled.
FDA Determined
Cause 2		Process control
ActionThe recalling firm issued a letter dated 6/1/2018 via email on 6/11/2018 to formally notify their customer of the reason for recall, discontinue distribution of the product, and complete the enclosed Product Recall Response Form for return via email.
Quantity in Commerce10/10-tube cases
DistributionDistribution was made to GA. The foreign recalling firm also distributed product 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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