KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Recall
- Recall Number
- Z-1055-2025
- Event Number
- 95975
- Firm
- Karl Storz Endoscopy
- FEI Number
- 3007475226
- Product Code
- FGB
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- December 19, 2024
- Posted
- January 30, 2025
- Address
- 2151 E Grand Ave, El Segundo, CA, 90245-5017
Description
KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
On December 19, 2024, Karl Storz, issued an "Urgent: Medical Device Correction" notification to affected consignees via UPS. In addition to informing consignees about the recall, Karl Storz asked consignees to take the following actions: 1. Immediately discard any previous revisions of the IFU. 2. Access the updated e-IFU at the following link: https://www.karlstorz.com/de/en/eifu.htm?q=&country=US 3. Pass on this Urgent Medical Device Correction to all users of the recalled products and all other persons who need to be aware within your organization. 4. If you have or may have distributed the products listed, please identify and promptly notify those recipients with a copy of this notice, response form and updated e-IFU. 5. Return the completed Customer Reply Form by Fax or E-Mail to the indicated contact below within 15 calendar days from the date of receipt. 6. Please report any incidents related to this issue to the manufacturer, dealer, or local representative and, if applicable, to the national competent authority, as this is important feedback. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
US Nationwide distribution.
1510 units