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U.S. Department of Health and Human Services

Class 2 Device Recall Urolift Visual Obturator

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  Class 2 Device Recall Urolift Visual Obturator see related information
Date Initiated by Firm June 23, 2023
Date Posted August 09, 2023
Recall Status1 Open3, Classified
Recall Number Z-2364-2023
Recall Event ID 92700
510(K)Number K150158  
Product Classification Hysteroscope (and accessories) - Product Code HIH
Product 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
Code Information UDI-DI: 04250480106617 Lot Number: 141980
Recalling Firm/
Manufacturer		 Scholly Fiberoptic Gmbh
Robert-Bosch-Str. 1-3
Denzlingen Germany
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
Action SCHOLLY FIBEROPTIC GMBH initiated Recall Plan Letter to Users, Importers and Distributors . The US Distributor- Teleflex (parent company of NeoTract) notified on June 23, 2023 to forward the notification letter to their customers. Letter states reason for recall, health risk and action to take: Review this Field Safety Notice in its entirety and ensure that all users of the above-mentioned product in your organization and other concerned persons are informed about this Field Safety Notice. 2. If you are a distributor, please forward this correction notification to your customers. 3. Identify, quarantine and return affected devices. 4. Do not use affected devices anymore. 5. Exchange devices from the above-mentioned batches, which are currently in use. 6. Confirm receipt of this information by filling in the attached reply form and returning it to the indicated e-mail address. E-Mail: vigilance@schoelly.de
Quantity in Commerce 98 units
Distribution Nationwide Foreign: Japan, South Korea
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HIH and Original Applicant = Schoelly Fiberoptic GmbH
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