BfArM - Federal Institute for Drugs and Medical Devices

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Product group Medical instruments for use in humans
Reference 01290/08

Recall of EEA Stapler (31 mm, 28 mm and 25 mm) of the DST series, which have no “H” after the third character in the lot number, from Covidien. Some applications, which are not the intended use according to the Instructions for Use, can result in excessive amount of tissue being incorporated into the barrel of the instrument potentially leading to a loss of anastomotic integrity. The firm has become aware of incidents with the products.

Recall EEA Stapler, Covidien , Download_VeroeffentlichtAm_EN PDF, 62KB, File does not meet accessibility standards