FDA Enforcement
Class II
Terminated
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.
Recall: Z-0936-2018
·
Reported March 21, 2018
Enforcement
- Recall Number
- Z-0936-2018
- Event ID
- 79352
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Minimally Invasive Therapies Group
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 21, 2018
- Initiation Date
- October 24, 2017
- Classification Date
- March 15, 2018
- Termination Date
- October 26, 2020
- Address
- 15 Hampshire St, Mansfield, MA, 02048-1113, United States
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
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 Info
710016864X
Distribution
USA (nationwide) Distribution
Quantity
58,954