Device product
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
Z-0890-2017
Product summary
- Firm
- Medtronic
- Event
- Event 75301
- Status
- Terminated
- Classification
- Class II
- Quantity
- 230 systems
- Official record key
device-enforcement:Z-0890-2017
Official wording
Reason: Product sterility is compromised due to breach of the sterile barrier
Code information: Kit Parent Codes: 00Z2224 00Z2232 00Z2298 00Z2363 00Z2364 00Z2365 00Z2366 00Z2421 00Z2425 00Z2430 00Z2431 00Z2460 00Z2493 00Z2534 00Z2535 000Z2544 00Z5000B 00Z5001B GYNKIT2
Distribution pattern: 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 Serbia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom
Derived failure modes
-
Sterility assurance
sterility is compromised