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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 July 16, 2019
Create Date August 15, 2019
Recall Status1 Completed
Recall Number Z-2281-2019
Recall Event ID 83374
510(K)Number K100700  
Product Classification Tube, feeding - Product Code FPD
Product MED-RX POLYURETHANE FEEDING TUBES:
a) 5Fr X 16" (40cm), REF 54-1650R
b) 6.5Fr X16" (40cm), REF 54-1665R
c) 5Fr X 24" (60cm), REF 54-2450R
d) 6.5Fr X 24" (60cm), REF 54-2465R
e) 8Fr X 24: (60cm), REF 54-2480R
f) 8Fr X 36" (91cm), REF 54-3680R
Code Information a) 5Fr X 16" (40cm), REF 54-1650R, Lot Number 141487 b) 6.5Fr X16" (40cm), REF 54-1665R, Lot Number 141863 c) 5Fr X 24" (60cm), REF 54-2450R, Lot Numbers: 142844, 143130 d) 6.5Fr X 24" (60cm), REF 54-2465R, Lot Number 142843 e) 8Fr X 24: (60cm), REF 54-2480R, Lot Number 142870 f) 8Fr X 36" (91cm), REF 54-3680R, Lot Number 142842 
Recalling Firm/
Manufacturer		 Canadian Hospital Specialties
2760 Brighton Rd
Oakville Canada
Manufacturer Reason
for Recall		 The firm received a complaint that the connector detached from the feeding tube.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm initiated the recall by email on 07/16/2019. The notice requested the consignee cease distribution/use of the product, complete and return the product recall response form to arrange for product return and replacement/credit.
Quantity in Commerce 2870 units
Distribution GA and 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.
510(K) Database 510(K)s with Product Code = FPD and Original Applicant = BENLAN, INC.
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