Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 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
This recall has been terminated (originally issued July 8, 2016).
- Company
- Medtronic
- Recall Initiated
- July 8, 2016
- Terminated
- August 8, 2018
- Recall Number
- Z-2569-2016
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for compromise of the package resulting in a breach of the sterile barrier
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
Lot / Code Info
Affected Lot Range: 209716X through 61220115X
Root Cause
Process control
Action Taken
Medtronic/Covidien sent an Urgent Medical Device Recall letter dated July 8, 2016, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Customers with questions were instructed to contact their Medtronic representative or Customer Service at 800-882-5878.