The D*Clot HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposab
FDA device recall Z-2213-2024 · posted 2024-06-26 · Open, Classified
Recall details
- Recalling firm
- Mermaid Medical A/S
- Reason for recall
- Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
- Action taken
- The consignees and distributors were sent out the notification via email on 05/01/2024. The letter instructs the consignees to: 1. Quarantine and Discontinue Use of Affected Product: Identify, segregate, and discontinue use of the affected product in your inventory. 2. Complete and Return the attached Response Form: Complete the attached Response Form and return to Mermaid Medical by May 10, 2024 via email or by post. 3. Distributors/ If You Further Distributed Affected Product: Forward this communication to any customers that were distributed affected product. Instruct any of your customers to complete the response form and return to Mermaid Medical. Once they complete and return the response form, Mermaid Medical will provide instructions on how to return or destroy any affected product remaining in their inventory.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- QEW
- Quantity affected
- 190 devices
- Distribution
- Worldwide - US Nationwide distribution in the states of OH, MO, CO, NC, TX, MA, GA, FL, IL, IN, MD, PA, VA, and the country of Chile.
- Date initiated
- 2024-05-01
- Date posted
- 2024-06-26
- Location
- Stenlose, Denmark
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XTD THROMBECTOMY CATHETER, XX CM (K021641) | Xtrak Medical, Inc. | 2002-07-26 |