Z-0597-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 19, 2018
- Initiation Date
- October 31, 2018
- Termination Date
- May 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1522
Product Description
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 for Recall
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.
Distribution Pattern
Worldwide Distribution - US Nationwide and foreign distribution to Canada.
Code Information
1812115564