Recall Z-0890-2017 ยท FEI Instrument, Special Lens, For Endoscope
Medtronic
Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
| Date | Oct 4, 2016 |
| Status | Terminated |
| Reason | Product sterility is compromised due to breach of the sterile barrier |
| Root cause | Employee error |
| Action | Covidien issued an Urgent Medical Device Recall letter on October 4, 2016 and a corrected letter on October 10, 2016 to US Customers via Federal Express. 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. Disposition of product within Medtronic control and customer returned devices will be reworked. Questions or concerns, contact your Medtronic representative or customer service at 800-882-5878. |
| Quantity | 230 systems |
| Distribution | Worldwide Distribution - US (Nationwide) Foreign: Austria Belgium Bulgaria Brazil Chile Cyprus Denmark Egypt Finland France France Germany Greece Hungary Iran Ireland Israel Italy Japan Kenya Kuwait Latvia Luxembourg Mexico Namibia Netherlands Nigeria Norway Poland Portugal Romania Saudi Arabia Serb |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062779 | DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) New Wave Surgical Corporation, Oct 5, 2006 |