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Recall Observatory FDA recall evidence

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

October 31, 2018

Class II

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

    reason.labeling_packaging · v1.0.0

    incorrect packaging