Mar-Med Co Recall 87009
Description: Tourni-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.
Mar-Med Co Recall 87009 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0945-2021 |
Event ID | 87009 |
Event Description | Tourni-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. |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Germany, Greece, Italy, Japan, Netherlands, Singapore, Spain, Sweden, Switzerland, and United Kingdom. |
Quantity | 52,000 |
Recall Reason | 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. |
Device Classification | 20210210 |
Device Code Info | All lots |
Center Classification Date | 20210202 |
Recall Initiation Date | 20201228 |
Recalling Firm | Mar-Med Co |
Initial Notification | Letter |
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