Recall record at a glance
| Official record | Z-2364-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Scholly Fiberoptic Gmbh |
| Report date | Aug 16, 2023 |
| Recall initiation date | Jun 23, 2023 |
| Quantity | 98 units |
| Location | Denzlingen, N/A, Germany |
Official product description
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO
Why the product was recalled
There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occur. Contamination can occur in this capillary gap, which is not covered by the reprocessing validations performed.
Distribution information
Nationwide Foreign: Japan, South Korea
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: E-Mail.
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
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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