Z-0725-2019Class II

MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector...

Name: Z-0725-2019 MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector...
Creator: Canadian Hospital Specialties
Published: 2018-12-01
License: https://open.fda.gov/license/

Canadian Hospital Specialties Ltd. / initiated 2018-12-01 / Terminated / root cause: labeling and UDI

FDA source

Canadian Hospital Specialties began a recall of MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A... on 2018-12-01. FDA classified it as Class II and gives the reason as "The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0725-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-01
Posted: 2019-01-11
Terminated: 2021-04-02
Recalling firm: Canadian Hospital Specialties Ltd.
Product: MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician.
Product code: FPD Tube, Feeding
Reason for recall: The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm notified its consignees of the recall by email on 12/01/2018. The letter identified the affected product, problem and actions to be taken. The firm requested return of the product.
Quantity in commerce: 75 cases of 10
Distribution: US in the states of TN
Product codes and lots: Lot 139457

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0725-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0725-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-11

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)