FDA Medical Device Recalls (openFDA)
Covidien LLC: 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.
- Recall number
- Z-1033-2016
- Recalling firm
- Covidien LLC
- 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.
- Status
- Terminated
- Initiated
- 2016-01-21
- Posted
- 2016-03-02
- Terminated
- 2017-06-01
- Reason
- 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
- 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
- 1,010 units
- Distribution
- Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.
- Lot, serial or model codes
- Lot Code: 521807764X
- 510(k) numbers
- ["K820442"]
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28