Recall Z-0595-2016— Benlan, Inc.

Name: FDA recall Z-0595-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-11

Class II · Terminated

Class II FDA medical device recall by Benlan, Inc., initiated 2015-12-11, terminated 2016-10-31. It names one FDA 510(k) clearance: K100700. Product: 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: The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size..

Recalling firm: Benlan, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-12-11
Terminated: 2016-10-31
Firm location: Oakville, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K100700 — MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIESBenlan, Inc.·cleared 2010-12-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.