Salem Sump™ products
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
Cardinal Health Canada
1000 Tesma Way, Vaughan, Ontario, Canada, L4K 5R8
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