Z-1033-2016Class II

Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x...

Name: Z-1033-2016 Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x...
Creator: Covidien LLC
Published: 2016-01-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-01-21 / Terminated / root cause: labeling and UDI

FDA source

Covidien LLC began a recall of 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... on 2016-01-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1033-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-21
Posted: 2016-03-02
Terminated: 2017-06-01
Recalling firm: Medtronic, Inc.
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.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
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
Root cause tag: labeling and UDI
FDA 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 in commerce: 1,010 units
Distribution: Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.
Product codes and lots: Lot Code: 521807764X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1033-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1033-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-03-02
Z-1034-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-03-02

Product code KNT

K820442Class IIArgyle Indwell Feeding TubeSherwood Medical Co. / cleared 1982-03-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)