Recall record at a glance
| Official record | Z-2706-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Richard Wolf GmbH |
| Report date | Aug 5, 2020 |
| Recall initiation date | Jun 5, 2020 |
| Quantity | 338 sets |
| Location | Knittlingen, N/A, Germany |
Official 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.
Why the product was recalled
Tube material of a smaller diameter was used.
Distribution information
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).
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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