Tonbridge, United Kingdom
Boddingtons Plastics Ltd recalls
1 recall recorded since 2018, most recently on 11 March 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 March 2020
- Terminated
- 10 August 2022
- Reason
- Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)
- Distribution
- Nationwide Foreign:
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1718-2020
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.