FDA-Device2016-01-13Class II

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

Benlan, Inc.
Hazard

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

Sold states
Worldwide Distribution - US including GA & Internationally to Canada.
Affected count
120 units
Manufactured in
2760 Brighton Road, N/A, Oakville, N/A, Canada
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0595-2016

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