CLASS II Device recall · Reported 25 Jul 2018 · FDA Enforcement Report

Med-rx, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube recalled

Canadian Hospital Specialties is recalling Med-rx, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube, distributed in Georgia. The recall was initiated on 11 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #135137

Quantity recalled10/10-tube cases

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-2440-2018
FDA event ID: 80374
Recalling firm: Canadian Hospital Specialties, Oakville
Classification: Class II
Status: Terminated
Recall initiated: 11 Jun 2018
FDA classified: 18 Jul 2018
Reported: 25 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

11 Jun 2018	Recall initiated by company
18 Jul 2018	Classified by FDA	+37 days
25 Jul 2018	Published in enforcement report	+7 days

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

Reason for recall

The product may be packaged with the incorrect length of feeding tube as labeled.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

Distribution was made to GA. The foreign recalling firm also distributed product to Canada.

Georgia

Questions about this recall

Why was it recalled?

The product may be packaged with the incorrect length of feeding tube as labeled.

Which lots are affected?

Lot #135137

Where was it sold?

Distribution was made to GA. The foreign recalling firm also distributed product to Canada.

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
21 Aug 2019Device	CLASS II	Med-rx Polyurethane Feeding Tubes: a) recalled	Canadian Hospital Specialties	Other	GA, TN
23 Jan 2019Device	CLASS II	Med-rx Polyurethane Feeding Tube For Pediatric Use recalled	Canadian Hospital Specialties	Packaging Defects	TN

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