Z-0595-2016Class II

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

Name: Z-0595-2016 MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange...
Creator: Benlan, Inc.
Published: 2015-12-11
License: https://open.fda.gov/license/

Canadian Hospital Specialties Ltd. / initiated 2015-12-11 / Terminated / root cause: packaging

FDA source

Benlan, Inc. began a recall of 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... on 2015-12-11. FDA classified it as Class II and gives the reason as "The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0595-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-11
Posted: 2016-01-06
Terminated: 2016-10-31
Recalling firm: Canadian Hospital Specialties Ltd.
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
Product code: FPD Tube, Feeding
Reason for recall: The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.
Root cause tag: packaging
FDA root cause: Under Investigation by 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.
Quantity in commerce: 120 units
Distribution: Worldwide Distribution - US including GA & Internationally to Canada.
Product codes and lots: Lots 114842, 116433 & 118251

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0595-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0595-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-06

Product code FPD

K100700Class IIMed-Rx Pediatric Feeding Tubes and AccessoriesBenlan, Inc. / cleared 2010-12-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)