Z-2440-2018Class II

MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque...

Name: Z-2440-2018 MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque...
Creator: Canadian Hospital Specialties
Published: 2018-06-11
License: https://open.fda.gov/license/

Canadian Hospital Specialties Ltd. / initiated 2018-06-11 / Terminated / root cause: manufacturing process

FDA source

Canadian Hospital Specialties began a recall of MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 10/case... on 2018-06-11. FDA classified it as Class II and gives the reason as "The product may be packaged with the incorrect length of feeding tube as labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2440-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-11
Posted: 2018-07-13
Terminated: 2019-03-13
Recalling firm: Canadian Hospital Specialties Ltd.
Product: MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 10/case, Sterile, RX. The firm name on the label is chs, Oakville, ON, Canada.
Product code: FPD Tube, Feeding
Reason for recall: The product may be packaged with the incorrect length of feeding tube as labeled.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm issued a letter dated 6/1/2018 via email on 6/11/2018 to formally notify their customer of the reason for recall, discontinue distribution of the product, and complete the enclosed Product Recall Response Form for return via email.
Quantity in commerce: 10/10-tube cases
Distribution: Distribution was made to GA. The foreign recalling firm also distributed product to Canada.
Product codes and lots: Lot #135137

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2440-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2440-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-18

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)