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Recall Observatory FDA recall evidence

Device product

Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device and also includes a male connector that can be used for devices designed with female connectors, This product is sterile, non-conductive and latex free.

Z-0936-2018

October 24, 2017

Class II

Product summary

Firm
Medtronic Minimally Invasive Therapies Group
Event
Event 79352
Status
Terminated
Classification
Class II
Quantity
58,954
Official record key
device-enforcement:Z-0936-2018

Official wording

Reason: Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as the Salem Sump Dual Lumen Stomach Tube. This product may have been distributed within the case of Argyle Suction Tubing.

Code information: 710016864X

Distribution pattern: USA (nationwide) Distribution

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled