Benlan, Inc. recalls MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque S…

Recall date

December 11, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0595-2016

FDA classification

Class II

Brand / firm

Benlan, Inc.

Sold / distributed

Worldwide Distribution - US including GA & Internationally to Canada.

Why it was recalled

The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.

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

What was recalled

MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada