Recalls / —
—#143084
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.
- FDA product code
- KNT — Tubes, Gastrointestinal (And Accessories)
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K820442
- Affected lot / code info
- Lot Code: 521808064X
Why it was recalled
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
Root cause (FDA determination)
Labeling Change Control
Action the firm took
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.
Recalling firm
- Firm
- Covidien LLC
- Address
- 60 Middletown Ave, North Haven, Connecticut 06473-3908
Distribution
- Distribution pattern
- Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.
Timeline
- Recall initiated
- 2016-01-21
- Posted by FDA
- 2016-03-02
- Terminated
- 2017-06-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #143084. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.