Recall Z-0936-2018— Medtronic Minimally Invasive Therapies Group

Class II · Terminated

Class II FDA medical device recall by Medtronic Minimally Invasive Therapies Group, initiated 2017-10-24, terminated 2020-10-26. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..

Recalling firm
Medtronic Minimally Invasive Therapies Group
Classification
Class II
Status
Terminated
Initiated
2017-10-24
Terminated
2020-10-26
Firm location
Mansfield, MA, United States

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.