Medical device recalls Moderate risk

Covidien LLC recalls Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm),…

Recall date
January 21, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1033-2016
FDA classification
Class II
Brand / firm
Covidien LLC
Sold / distributed
Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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