The D*Clot¿ HD Rotational Thrombectomy System is a recall: Sterility Concern
The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an…
Why was The D*Clot¿ HD Rotational Thrombectomy System is a recalled?
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Unique Device Identifier: 15711055004333; Lot codes: S2306001; Model Number: T10106065
- Product
- The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an…
- Recalling firm
- Mermaid Medical A/S
- Quantity
- 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.
- Recall date
- July 3, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)