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FDA Stamps Recall Of Teleflex Percutaneous Thrombolytic Device As Class I

 
• By Brian Bossetta

The US FDA has designated a September recall by Teleflex of its Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR as high-risk class I.

Teleflex
• Source: Alamy

The US Food and Administration has slapped its most severe classification, class I, on a recall of Teleflex’s Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR. The product works in conjunction with the Arrow Rotator Drive Unit to clear clotted native arterio-venous fistulae and synthetic dialysis grafts.

Teleflex initiated its recall in September through a field safety corrective action after receiving reports that the inner orange...

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