medical Class II Updated 2020-08-05

Richard Wolf GmbH recalls Tube Set for TEM - Product Usage: Transanal Endoscopic Micro

Recalled 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.

Hazard / Issue

Tube material of a smaller diameter was used.

Issued by

FDA

Affected States: CA, DE
Lot/Code Info: Lot Number 32324159, Model # 4170.801
View official government recall

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