FDA Enforcement
Class II
Ongoing
Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
Recall: Z-3224-2024
·
Reported October 2, 2024
Enforcement
- Recall Number
- Z-3224-2024
- Event ID
- 95220
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Karl Storz Endoscopy
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 2, 2024
- Initiation Date
- July 23, 2024
- Classification Date
- September 24, 2024
- Address
- 2151 E Grand Ave, El Segundo, CA, 90245-5017, United States
Description
Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
Reason
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Code Info
All Lots/UDI: (01)04048551234099
Distribution
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
Quantity
5 units