Device product
Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 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
Z-2566-2016
Product summary
- Firm
- Medtronic
- Event
- Event 74602
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24870
- Official record key
device-enforcement:Z-2566-2016
Official wording
Reason: Potential for compromise of the package resulting in a breach of the sterile barrier
Code information: Affected Lot Range: 210409X through 61220133X
Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
Derived failure modes
-
Sterility assurance
breach of the sterile barrier