Recall Z-1718-2020— Boddingtons Plastics Ltd
Class II · Terminated
Class II FDA medical device recall by Boddingtons Plastics Ltd, initiated 2020-03-11, terminated 2022-08-10. It names one FDA 510(k) clearance: K151801. Product: 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: Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device).
- Recalling firm
- Boddingtons Plastics Ltd
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-11
- Terminated
- 2022-08-10
- Firm location
- Tonbridge, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.