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Recall Observatory FDA recall evidence

Device 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

Z-1718-2020

March 11, 2020

Class II

Product summary

Firm
Boddingtons Plastics Ltd
Event
Event 85214
Status
Terminated
Classification
Class II
Quantity
13202 Units US
Official record key
device-enforcement:Z-1718-2020

Official wording

Reason: Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)

Code information: All batches distributed prior to 1st May 2020.

Distribution pattern: Nationwide Foreign:

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)