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Terminated

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

FDA Recall Z-0595-2016 · Posted None

Recalling FirmBenlan, Inc.
Recall StatusTerminated
Product CodeFPD
Date Initiated2015-12-11
Date Terminated2016-10-31
Product Quantity120 units

Reason for Recall

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

Firm Action

Benlan, Inc. sent a Product Recall Notification letter dated December 11, 2015, to all affected customers. Customers were asked to examine their stock and to discontinue/use of the product and return product. The letter included a response form which was to be returned via fax to 905-825-9600. Customers with questions were instructed to call 905-825-9300.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - US including GA & Internationally to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100700MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIESBenlan, Inc. · 2010-12-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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