Z-0890-2017 Class II Terminated
FDA device recall Z-0890-2017 was initiated by Medtronic on Oct 4, 2016 and is designated Class II. Reason for recall: Product sterility is compromised due to breach of the sterile barrier The recall status is terminated (terminated Aug 8, 2018). Affected quantity: 230 systems.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 28, 2016
- Initiation Date
- Oct 4, 2016
- Termination Date
- Aug 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 230 systems
Product Description
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
Reason for Recall
Product sterility is compromised due to breach of the sterile barrier
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
Code Information
Kit Parent Codes: 00Z2224 00Z2232 00Z2298 00Z2363 00Z2364 00Z2365 00Z2366 00Z2421 00Z2425 00Z2430 00Z2431 00Z2460 00Z2493 00Z2534 00Z2535 000Z2544 00Z5000B 00Z5001B GYNKIT2
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0890-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026