Karl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 65 Uretero-Renoscope units because the instructions contain reprocessing procedures that have not been FDA-reviewed or approved.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall involves unapproved reprocessing procedures for an invasive medical device. While no adverse events are reported, improper reprocessing creates a defined risk of patient harm.
Plain-English summary
Karl Storz Endoscopy is recalling 65 Uretero-Renoscope units (model REF 27000L, 7 Fr., 6°, 43 cm) distributed nationwide in the United States.
The Instructions for Use (IFU) for these devices contain reprocessing modalities that have not been reviewed and/or approved by the FDA for safety and efficacy.
Healthcare facilities currently using these devices should contact Karl Storz Endoscopy for clarification on proper reprocessing procedures. The FDA is monitoring this recall. Affected units are identified by UDI 04048551311271.
The recalled product
- Product
- KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- unapproved-reprocessing-procedures
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots/UDI: 04048551311271
Distribution
Distributed nationwide across the United States.
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