Z-1718-2020 Class II Terminated
FDA device recall Z-1718-2020 was initiated by Boddingtons Plastics Ltd on March 11, 2020 and is designated Class II. Reason for recall: Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device) The recall status is terminated (terminated August 10, 2022). Affected quantity: 13202 Units US.
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2020
- Initiation Date
- March 11, 2020
- Termination Date
- August 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13202 Units US
Product Description
Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds
Reason for Recall
Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)
Distribution Pattern
Nationwide Foreign:
Code Information
All batches distributed prior to 1st May 2020.