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 |
| Similar To |