Karl Storz Pediatric Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz Endoscopy is recalling its Pediatric Uretero-Renoscope 7.3 Fr. due to unapproved reprocessing instructions. The device instructions contain procedures not reviewed or approved by the FDA for safety and efficacy.
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 is an FDA Class II recall of a surgical device. The reprocessing instructions have not been reviewed or approved by the FDA for safety and efficacy, presenting a risk of improper device preparation and potential patient harm. No injuries have been reported, placing this at High severity rather than Severe per the FDA classification and absence of reported harm.
Plain-English summary
Karl Storz Endoscopy is recalling the KARL STORZ Pediatric Uretero-Renoscope 7.3 Fr., a medical device used in pediatric urological procedures. A total of 39 units were distributed nationwide in the United States with UDI 04048551231234.
The device's instructions contain reprocessing modalities that have not been reviewed or approved by the FDA for safety and efficacy. Reprocessing is the process used to clean, sterilize, and prepare medical devices for reuse in clinical settings. Proper reprocessing procedures are critical to ensuring patient safety during surgical procedures.
This is a Class II recall from the FDA. The recall addresses the lack of FDA review and approval for the reprocessing procedures included in the device's instructions.
The recalled product
- Product
- KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- unapproved-reprocessing
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: 04048551231234
Distribution
Distributed nationwide across the United States.
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