Date Initiated by Firm |
January 21, 2016 |
Date Posted |
March 02, 2016 |
Recall Status1 |
Terminated 3 on June 01, 2017 |
Recall Number |
Z-1034-2016 |
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 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701.
Intended for pediatric feeding.
|
Code Information |
Lot Code: 521808064X |
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 |
1,330 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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