Reported Apr 22, 2020 · Terminated
Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of…
Boddingtons Plastics Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boddingtons Plastics Ltd · Wheelbarrow Park Estate · Tonbridge · N/A
Is this the product you have?
- Endocuff Vision
models ARV 110120130140
- Intended UseENDOCUFF 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
- Lot codes and dates
- All batches distributed prior to 1st May 2020.
- Amount recalled
- 13202 Units US
Where it was sold
- Nationwide
Why it was recalled
Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)
This product could cause temporary or reversible health problems — stop using it.
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