FDA Enforcement
Class II
Ongoing
Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
Recall: Z-1472-2024
·
Reported April 10, 2024
Enforcement
- Recall Number
- Z-1472-2024
- Event ID
- 94171
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Karl Storz Endoscopy
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 10, 2024
- Initiation Date
- February 27, 2024
- Classification Date
- April 3, 2024
- Address
- 2151 E Grand Ave, El Segundo, CA, 90245-5017, United States
Description
Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
Reason
Inadequate reprocessing validation evidence
Code Info
UDI: 04048551050255/ All Lots
Distribution
US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV.
Quantity
190 units