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U.S. Department of Health and Human Services

Class 2 Device Recall ARC Endocuff Vision: Models ARV 110, 120, 130 and 140

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 Class 2 Device Recall ARC Endocuff Vision: Models ARV 110, 120, 130 and 140see related information
Date Initiated by FirmMarch 11, 2020
Create DateApril 16, 2020
Recall Status1 Terminated 3 on August 10, 2022
Recall NumberZ-1718-2020
Recall Event ID 85214
510(K)NumberK151801 
Product Classification endoscopic access overtube, gastroenterology-urology - Product Code FED
ProductEndocuff 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
Code Information All batches distributed prior to 1st May 2020.  
FEI Number 3009837469
Recalling Firm/
Manufacturer		 Boddingtons Plastics Ltd
Wheelbarrow Park Estate
Pattenden Lane
Tonbridge United Kingdom
Manufacturer Reason
for Recall		Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)
FDA Determined
Cause 2		Other
ActionBoddingtons issued Medical Device Correction Notice dated 3/13/20 to the Distributor stating reason for correction and take the following actions: It is not necessary to return any Endocuff Vision you have in stock, as this recall affects the IFU and not the device. It can continue to be used, provided users are aware of the updated information in the IFU. Healthcare letters dated 3/2/620 was distributed There is no requirement to replace existing stock. New stock with the updated IFU will become available in May 2020. Ensure relevant staff members are informed of this recall, including locums, biomedical engineers, operating theatre staff and relevant clinicians who may decide to monitor for adverse events, as applicable. If you have supplied or transferred any potentially affected product to another facility or organisation, let that facility know of the recall immediately by providing a copy of this letter. Please complete the attached acknowledgement form immediately even if you do not have any affected stock and return it to mdr@boddingtons.co.uk or fax to 004401622833701 to enable Boddingtons to reconcile this process.
Quantity in Commerce13202 Units US
DistributionNationwide Foreign:
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = FED
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