In a field safety notice dated March 16, Teleflex announced that Arrow is voluntarily recalling the catheter due to a potential sterility issue.
The catheter’s product tray may be damaged in affected devices, leaving the sterility in question. If the device’s sterility is compromised and the catheter is used, it could lead to infectious complications.
Teleflex and Arrow have received no complaints, nor have they been informed of any patient injuries or deaths at present.
The company requested that users of the affected devices check inventories for the product and cease use and distribution while quarantining affected devices immediately. Teleflex said it will issue a credit note upon receipt of the returned affected product.
In January, Wayne, Pa.–based Teleflex issued a safety warning in the United Kingdom for its Arrow EZ-IO intraosseous vascular access needle sets due to a risk of needle stick injury. Last month, the company warned of failures with the loss of resistance (LOR) syringes including in Arrow epidural catheterization kits.