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.
Reported: August 5, 2020 Initiated: June 5, 2020 #Z-2706-2020
Product Description
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.
Reason for Recall
Tube material of a smaller diameter was used.
Details
- Recalling Firm
- Richard Wolf GmbH
- Units Affected
- 338 sets
- Distribution
- 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).
- Location
- Knittlingen, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Richard Wolf GmbH. Units affected: 338 sets.
Why was this product recalled? ▼
Tube material of a smaller diameter was used.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 5, 2020. Severity: Moderate. Recall number: Z-2706-2020.
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