Denzlingen, N/A, Germany
Scholly Fiberoptic Gmbh recalls
1 recall recorded since 2018, most recently on 23 June 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 June 2023
- Reason
- 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
- Nationwide Foreign: Japan, South Korea
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2364-2023
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.