Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Produc...

FDA Device Recall #Z-1845-2020 — Class II — July 16, 2019

Recall Summary

Recall Number Z-1845-2020
Classification Class II — Moderate risk
Date Initiated July 16, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm TeDan Surgical Innovations LLC
Location Sugar Land, TX
Product Type Devices
Quantity 2 units

Product Description

Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices that are connected to the hospital suction system to remove debris and blood from the surgical field.

Reason for Recall

There was incorrect raw material used in the production of the identified lot.

Distribution Pattern

US Nationwide distribution in the states of NJ.

Lot / Code Information

Lot: 0619

Other Recalls from TeDan Surgical Innovations LLC

Recall # Classification Product Date
Z-2526-2020 Class II PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, ... May 15, 2020
Z-2525-2020 Class II 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX -... May 15, 2020
Z-2529-2020 Class II PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM... May 15, 2020
Z-2530-2020 Class II PHANTOM CS QUICK START DISTRACTION SCREW, 16 M... May 15, 2020
Z-2528-2020 Class II PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM... May 15, 2020

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.