FDA Device recall Z-0597-2019
Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intende…
- FDA Device
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intende… by Covidien, citing this voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0597-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-31 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien |
| Distribution | US |
Product
Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illness, or surgery in patients with intestinal obstruction, and to prevent the distention of the stomach.
Reason
This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube when a 16Fr is needed could result in decreased fluid collection, with the potential to affect patient care, particularly in an emergency situation where the correct size is not readily available.
Identifiers
| code_info | 1812115564 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0597-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.