Richard Wolf GmbH recalls Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for

Recalled August 5, 2020 · FDA recall Z-2706-2020 · Richard Wolf

Hazard

Tube material of a smaller diameter was used. · FDA Class II

Units

338 sets

Sold at

International distribution in the countries of Austria (AT), Canada (CA), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Iceland (IS), Lithuania (LT), Norway (NO), New Zealand (NZ), Sweden (SE), and Netherlands (NL).

Description

Tube material of a smaller diameter was used.

Product

Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged.

Manufacturer(s)

Richard Wolf GmbH

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →