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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Kangaroo Polyurethane Feeding Tube

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  Class 2 Device Recall Covidien Kangaroo Polyurethane Feeding Tube see related information
Date Initiated by Firm January 21, 2016
Date Posted March 02, 2016
Recall Status1 Terminated 3 on June 01, 2017
Recall Number Z-1033-2016
Recall Event ID 73115
510(K)Number K820442  
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
Product Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438.

Intended for pediatric feeding.
Code Information Lot Code: 521807764X
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact Catherine Wrenn
203-492-5000
Manufacturer Reason
for Recall		 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs
FDA Determined
Cause 2		 Labeling Change Control
Action Medtronic/Covidien Customers notified via an Urgent Medical Device Recall letter, dated January 22, 2016. The letter identifies the affected product, instructs customers to discontinue use and quarantine any of the product, and return all affected inventory. Customers are also to complete the "Recalled Product Return Form." Questions or concerns can be directed to a Medtronic representative or Customer Service at 800-882-5878.
Quantity in Commerce 1,010 units
Distribution Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNT and Original Applicant = SHERWOOD MEDICAL CO.
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