Reported Aug 5, 2020 · Terminated
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for…
Richard Wolf GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Richard Wolf GmbH · Pforzheimer Str. 32 · Knittlingen, N/A · N/A
Is this the product you have?
- Tube Set for TEM - Product UsageTransanal 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
- Lot codes and dates
Lot Number 32324159Model # 4170.801
- Amount recalled
- 338 sets
Where it was sold
Why it was recalled
Tube material of a smaller diameter was used.
This product could cause temporary or reversible health problems — stop using it.
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