Z-1020-2019 Class II Terminated
FDA device recall Z-1020-2019 was initiated by Covidien, PLC on February 15, 2019 and is designated Class II. Reason for recall: Potential for the sterile packaging to be compromised The recall status is terminated (terminated June 17, 2020). Affected quantity: 850 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2019
- Initiation Date
- February 15, 2019
- Termination Date
- June 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 850 units
Product Description
Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F
Reason for Recall
Potential for the sterile packaging to be compromised
Distribution Pattern
US Nationwide Distribution
Code Information
Lot Number: 80390309X UDI-Device Identifier (GTIN/UPN) 10884524000084/ 20884524000081