Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use wi...

FDA Recall #Z-0595-2016 — Class II — December 11, 2015

Recall #Z-0595-2016 Date: December 11, 2015 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

Benlan, Inc. — Oakville, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

120 units

Distribution

Worldwide Distribution - US including GA & Internationally to Canada.

Code Information

Lots 114842, 116433 & 118251

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

Browse All Device Recalls Device Recall Stats Device Safety Home
Back to All Device Recalls