Karl Storz Uretero-Renoscope with Unapproved Reprocessing Instructions Recalled
Karl Storz Endoscopy is recalling 59 units of its uretero-renoscope due to instructions for use containing reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
- Product
- KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
- Category
- Medical Device
- Distribution
- Distributed nationwide