Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is in
FDA device recall Z-0945-2021 · posted 2021-02-02 · Terminated
Recall details
- Recalling firm
- Mar-Med Co
- 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.
- Action taken
- On 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GAX
- Quantity affected
- 52,000
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Germany, Greece, Italy, Japan, Netherlands, Singapore, Spain, Sweden, Switzerland, and United Kingdo
- Date initiated
- 2020-12-28
- Date posted
- 2021-02-02
- Date terminated
- 2023-09-14
- Location
- Grand Rapids, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FINGER TOURNIQUETTE (K853472) | Joseph B. Marogil | 1985-10-10 |