Health product recall

Salem Sump™ products

Last updated

Summary

Product
Salem Sump™ products
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Silicon Salem Sump™ W/ARV

All lots.

8888266288

Silicon Salem Sump™ W/ARV

All lots.

8888266221

Silicon Salem Sump™ W/ARV

All lots.

8888266247
8888266262
8888266213

Silicon Salem Sump™ W/ARV

All lots.

8888266262
8888266213

Silicon Salem Sump™ W/ARV

All lots.

8888266213

Argyle™ PVC Salem Sump™ W/ARV

All lots.

8888266106

Salem Sump™ Silicone Dual Lumen Stomach Tube Radiopaque Line

All lots.

8888265108

Salem Sump™ Silicone Dual Lumen Stomach Tube Radiopaque Line

All lots.

8888265140

Salem Sump™ Silicone Dual Lumen Stomach Tube Radiopaque Line

All lots.

8888265124

Salem Sump™ Silicone Dual Lumen Stomach Tube Radiopaque Line

All lots.

8888265116

Salem Sump™ Silicone Dual Lumen Stomach Tube Radiopaque Line

All lots.

8888265132

Salem Sump™ Dual Lumen Stomach Tube Anti-Reflux Valve

All lots.

266148

Salem Sump™ Dual Lumen Stomach Tube Anti-Reflux Valve

All lots.

8888266122

Salem Sump™ Dual Lumen Stomach Tube Anti-Reflux Valve

All lots.

8888266148

Salem Sump™ Dual Lumen Stomach Tube Anti-Reflux Valve

All lots.

266122

Salem Sump™ Dual Lumen Stomach Tube Anti-Reflux Valve

All lots.

266130

Salem Sump™ Dual Lumen Stomach Tube Anti-Reflux Valve

All lots.

8888266130

Salem Sump™ Dual Lumen Stomach Tube Anti-Reflux Valve

All lots.

8888266114

Argyle™ PVC Salem Sump™

All lots.

8888264929E

Argyle™ PVC Salem Sump™

All lots.

8888264960E

Argyle™ PVC Salem Sump™

All lots.

8888268060

Argyle™ PVC Salem Sump™

All lots.

264960

Argyle™ PVC Salem Sump™

All lots.

8888264960

Argyle™ PVC Salem Sump™

All lots.

8888268086

Argyle™ PVC Salem Sump™

All lots.

264929

Argyle™ PVC Salem Sump™

All lots.

8888264945E

Argyle™ PVC Salem Sump™

All lots.

8888264986

Argyle™ PVC Salem Sump™

All lots.

264986

Argyle™ PVC Salem Sump™

All lots.

8888264945

Argyle™ PVC Salem Sump™

All lots.

8888268060E

Argyle™ PVC Salem Sump™

All lots.

8888264911E

Argyle™ PVC Salem Sump™

All lots.

8888264986E

Argyle™ PVC Salem Sump™

All lots.

264945

Argyle™ PVC Salem Sump™

All lots.

8888264911

Argyle™ PVC Salem Sump™

All lots.

8888264929

Argyle™ PVC Salem Sump™

All lots.

8888268086E

Salem Sump™ Anti-Reflux Valve

All lots.

8888266197

Salem Sump™ Anti-Reflux Valve

All lots.

266197

Salem Sump™ Dual Lumen Stomach Tube Anti-Reflux Valve W/ ENFit® Connection

All lots.

8888266106E

Salem Sump™ Dual Lumen Stomach Tube Anti-Reflux Valve W/ ENFit® Connection

All lots.

8888266122E

Salem Sump™ Dual Lumen Stomach Tube Anti-Reflux Valve W/ ENFit® Connection

All lots.

8888266130E

Salem Sump™ Dual Lumen Stomach Tube Anti-Reflux Valve W/ ENFit® Connection

All lots.

8888266114E

Salem Sump™ Dual Lumen Stomach Tube Anti-Reflux Valve W/ ENFit® Connection

All lots.

8888266148E

Issue

Cardinal Health has created an electronic instruction for use (eIFU) for Salem Sump™ products because of reports of breakage in the ARV due to improper use of the device. These changes to the labeling have been made to increase user awareness of how to use the ARV correctly and to inform users of the new warning. Lots manufactured after May 1, 2019 are affected.

Recall start date: July 22, 2024

Cardinal Health is issuing an update to the urgent medical device product correction originally issued in July 2024, on all lots of Salem Sump™ product codes listed that were manufactured from August 1, 2020. 

The purpose of this update is to provide additional guidance on how to properly use the Anti-Reflux Valve (ARV).

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies

Cardinal Health Canada

1000 Tesma Way, Vaughan, Ontario, Canada, L4K 5R8

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-75939

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