Data Foundry

Medical device recalls 2016

Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line — Class II medical device recall Z-1034-2016

Terminated recall by Covidien LLC, reported 2016-03-09, distributed in CA. 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8

Recall numberZ-1034-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCovidien LLC, North Haven, CT, United States
Recall initiated2016-01-21
Classified2016-03-02
Reported by FDA2016-03-09
Terminated2017-06-01
DistributedCA
Countries outside the USAU
Quantity1,330 units
Lot numbers521808064X
Model numbers461701

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.

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1034-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.