CLASS II Device recall · Reported 21 Aug 2019 · FDA Enforcement Report

Med-rx Polyurethane Feeding Tubes: a) recalled

Canadian Hospital Specialties is recalling Med-rx Polyurethane Feeding Tubes: a), distributed in Georgia, Tennessee. The recall was initiated on 16 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 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

Quantity recalled2870 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2281-2019
FDA event ID: 83374
Recalling firm: Canadian Hospital Specialties, Oakville, N/A
Classification: Class II
Status: Terminated
Recall initiated: 16 Jul 2019
FDA classified: 15 Aug 2019
Reported: 21 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Jul 2019	Recall initiated by company
15 Aug 2019	Classified by FDA	+30 days
21 Aug 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The firm received a complaint that the connector detached from the feeding tube.

Product as listed by the FDA

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

Where it was distributed

GA and TN

Georgia Tennessee

Questions about this recall

Why was it recalled?

The firm received a complaint that the connector detached from the feeding tube.

Which lots are affected?

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

Where was it sold?

GA and TN

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Canadian Hospital Specialties

All 5

Reported	Class	Recall	Company	Reason	Where
24 Jul 2024Device	CLASS II	High Flow Insufflation Tubing (with Filter) recalled	Canadian Hospital Specialties	Sterility	Nationwide
23 Nov 2022Device	CLASS III	Med-rx Urological Cysto/bladder Irrigation Set recalled	Canadian Hospital Specialties	Packaging Defects	N/A
23 Jan 2019Device	CLASS II	Med-rx Polyurethane Feeding Tube For Pediatric Use recalled	Canadian Hospital Specialties	Packaging Defects	TN
25 Jul 2018Device	CLASS II	Med-rx, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube recalled	Canadian Hospital Specialties	Packaging Defects	GA

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