PTFE (Polytetrafluoroethylene) felt…

Date posted by the FDA

June 25, 2005

Status

Terminated

Filed by

Boston Scientific Scimed

Product

PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.

Reason

Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.

Distribution pattern

The product was distributed to hospitals nationwide.

Quantity

290 packs containing 5 pieces of Felt.

Codes and lots

Lot Numbers: 7337514; 7337515; 7337516; 7337717; 7350604; 7356745; 7356747; 7359759; 7359760; 7360535; 7360536; 7384480; 7384483; 7384484; 7384485; 7384486; 7384487; 7412113.

Recall started

April 19, 2005

Device type

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Root cause (FDA)

Other

What the company told customers

Recall letters letters were sent to all customers on 4/19/2005 with instructions to discontinue using the identified felt products.

Recall number

Z-0931-05

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0931-05. The agency record governs; check it and the company before acting.