Z-0889-2017 Class II Terminated
FDA device recall Z-0889-2017 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: 1,293,169 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
- 1,293,169 systems
Product Description
Covidien 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
Lots beginning with: P4J, P4K, P4L, P4M, P5A, P5B, P5C, P5D, P5E, P5F, P5G, P5H, P5J, P5K, P5L, P5M, P6A, P6B, P6C, P6D and lots P6E0016GX,P6E0049GX, , P6E0050GX, P6E0051GX, P6E0052GX, P6E0163GX, P6E0164GX, P6E0212GX
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0889-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026