Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used a...

FDA Device Recall #Z-0936-2018 — Class II — October 24, 2017

Recall Summary

Recall Number Z-0936-2018
Classification Class II — Moderate risk
Date Initiated October 24, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medtronic Minimally Invasive Therapies Group
Location Mansfield, MA
Product Type Devices
Quantity 58,954

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.

Distribution Pattern

USA (nationwide) Distribution

Lot / Code Information

710016864X

Other Recalls from Medtronic Minimally Invasive Therapie...

Recall # Classification Product Date
Z-1007-2018 Class II MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen ... Oct 14, 2017

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.