Z-2281-2019Class II

MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c)...

Name: Z-2281-2019 MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c)...
Creator: Canadian Hospital Specialties
Published: 2019-07-16
License: https://open.fda.gov/license/

Canadian Hospital Specialties Ltd. / initiated 2019-07-16 / Terminated

FDA source

Canadian Hospital Specialties began a recall of MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24"... on 2019-07-16. FDA classified it as Class II and gives the reason as "The firm received a complaint that the connector detached from the feeding tube". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2281-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-16
Posted: 2019-08-15
Terminated: 2025-05-28
Recalling firm: Canadian Hospital Specialties Ltd.
Product: MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R
Product code: FPD Tube, Feeding
Reason for recall: The firm received a complaint that the connector detached from the feeding tube.
FDA root cause: Under Investigation by firm
Action: The firm initiated the recall by email on 07/16/2019. The notice requested the consignee cease distribution/use of the product, complete and return the product recall response form to arrange for product return and replacement/credit.
Quantity in commerce: 2870 units
Distribution: GA and TN
Product codes and lots: a) 5Fr X 16" (40cm), REF 54-1650R, Lot Number 141487 b) 6.5Fr X16" (40cm), REF 54-1665R, Lot Number 141863 c) 5Fr X 24" (60cm), REF 54-2450R, Lot Numbers: 142844, 143130 d) 6.5Fr X 24" (60cm), REF 54-2465R, Lot Number 142843 e) 8Fr X 24: (60cm), REF 54-2480R, Lot Number 142870 f) 8Fr X 36" (91cm), REF 54-3680R, Lot Number 142842

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2281-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2281-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-15

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)