Z-2578-2016 Class II Terminated
FDA device recall Z-2578-2016 was initiated by Medtronic on Jul 8, 2016 and is designated Class II. Reason for recall: Potential for compromise of the package resulting in a breach of the sterile barrier The recall status is terminated (terminated Aug 8, 2018).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 24, 2016
- Initiation Date
- Jul 8, 2016
- Termination Date
- Aug 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Valleylab Laparoscopic Cylindrical Tip Electrode 28CM Item Code: E278628 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Reason for Recall
Potential for compromise of the package resulting in a breach of the sterile barrier
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
Code Information
Affected Lot Range: 213786X through 61220121X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2578-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026