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U.S. Department of Health and Human Services

Class 2 Device Recall TourniCot Universal

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 Class 2 Device Recall TourniCot Universalsee related information
Date Initiated by FirmDecember 28, 2020
Date PostedFebruary 02, 2021
Recall Status1 Terminated 3 on September 14, 2023
Recall NumberZ-0945-2021
Recall Event ID 87009
510(K)NumberK853472 
Product Classification Tourniquet, nonpneumatic - Product Code GAX
ProductTourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.
Code Information All lots
Recalling Firm/
Manufacturer		 Mar-Med Co
333 Fuller Ave Ne
Grand Rapids MI 49503-3630
For Additional Information ContactJerry Marogil
616-454-3000
Manufacturer Reason
for Recall		A failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on it. The device may tear into two pieces with a portion remaining in place, which can continue to constrict the vessels. This type of failure can result in digit ischemia.
FDA Determined
Cause 2		Device Design
ActionOn December 28, 2020, the firm began notifying customers of the recall via Urgent Medical Device Correction letters. Customers were informed that serious injury could occur due to the failure mode associated with the correction. Actions to be taken by the Customer: Ensure proper removal of the Uni-Cot device by completely severing it from the digit, followed by verification that none of the device is remaining. Actions being taken by Mar-Med: Phase 1: Include a notice in each box of the device that identifies the risk for the users of this type of failure and provides specific guidance on how to avoid it. Phase 2: Include a warning tag on the device. The warning tag will not release unless the device is completely removed from the digit. Phase 3: In the near future an update will be made to the design of the device to better address usability and removal, maintaining the inclusion of the warning tag. An updated IFU will also be designed to provide clearer instructions and warnings. Please contact Mar-Med with any questions or information about this type of failure at 616-454-3000 or at info@marmed.com.
Quantity in Commerce52,000
DistributionWorldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Germany, Greece, Italy, Japan, Netherlands, Singapore, Spain, Sweden, Switzerland, and United Kingdom.
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 = GAX
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