Mermaid Medical A/S: The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rota

Hazard

Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.

Details from the source

Reason for recall: Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact. 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. Quantity: 190 devices Lot/code info: Unique Device Identifier: 15711055004333; Lot codes: S2306001; Model Number: T10106065

UPC codes

15711055004333

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.