Device 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.
Z-0597-2019
Product summary
- Firm
- COVIDIEN LLC
- Event
- Event 81560
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1522
- Official record key
device-enforcement:Z-0597-2019
Official wording
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.
Code information: 1812115564
Distribution pattern: Worldwide Distribution - US Nationwide and foreign distribution to Canada.
Derived failure modes
-
Labeling or packaging
incorrect packaging