The United Kingdom today issued a safety notice to warn on the Pilling Clear Advantage aortic punch manufactured by Teleflex (NYSE:TFX).
Teleflex recalled the Pilling Clear Advantage aortic punch in January after discovering the potential for compromised device packaging. If the packaging is compromised, the sterility of the device can’t be guaranteed, meaning use could result in contamination and infection. At the time of the recall, Teleflex had received zero complaints or reports of injuries or death.
The U.K. government released today’s notice after Teleflex reported that it hadn’t received enough replies to its own field safety notice. Molnlycke issued a separate field safety notice as the device is included as part of a procedure pack that it supplies.
According to the notice, users are urged to identify and quarantine affected devices, then return the unused, affected stock to Teleflex or a separate supplier. Users were told toget actions underway by May 4 and complete their actions by June 3.