CLASS II Device recall · Reported 9 Mar 2016 · FDA Enforcement Report
Kangaroo Polyurethane Feeding Tube Radiopaque Line recalled by Covidien
Covidien is recalling Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections/Ch x 20", distributed in California. The recall was initiated on 21 Jan 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1034-2016
- FDA event ID
- 73115
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jan 2016
- FDA classified
- 2 Mar 2016
- Reported
- 9 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 21 Jan 2016 | Recall initiated by company | |
| 2 Mar 2016 | Classified by FDA | +41 days |
| 9 Mar 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.
Questions about this recall
Why was it 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
Which lots are affected?
Lot Code: 521808064X
Where was it sold?
Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 73115This product is part of a recall event; the main page for the event is Kangaroo Polyurethane Feeding Tube Radiopaque Line recalled by Covidien.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Kangaroo Polyurethane Feeding Tube Radiopaque Line recalled by Covidien | Covidien | Packaging Defects | CA |
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