Recall Z-2556-2016 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Medtronic
Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" Item Code: E25306 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
| Date | Jul 8, 2016 |
| Status | Terminated |
| Reason | Potential for compromise of the package resulting in a breach of the sterile barrier |
| Root cause | Process control |
| Action | 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. |
| Quantity | 19200 |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K926481 | VALLEYLAB MODEL E252OH, FORCE GSU(TM) HANDSET Valleylab, Inc., Feb 12, 1994 |