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U.S. Department of Health and Human Services

Class 2 Device Recall Nephroscope for MIP L

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 Class 2 Device Recall Nephroscope for MIP Lsee related information
Date Initiated by FirmJuly 23, 2024
Date PostedSeptember 24, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3225-2024
Recall Event ID 95220
510(K)NumberK232370 
Product Classification Kit, nephroscope - Product Code FGA
ProductKarl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
Code Information All Lots/UDI: (01)04048551366660
FEI Number 3007475226
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy
2151 E Grand Ave
El Segundo CA 90245-5017
For Additional Information ContactMrs. Kath Strange
424-218-8201
Manufacturer Reason
for Recall		Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
FDA Determined
Cause 2		Process design
ActionOn August 2, 2024, Karl Storz -Endoskope issued a "Urgent: Medical Device Correction" Notification to affected consignees via UPS Ground. Karl Storz asked consignees to take the following actions: 1. Immediately discard any previous revisions of the IFU. 2. Access the updated e-IFU at Karl Storz website 3. Pass on this Urgent Medical Device Correction to all users of the products listed and all other persons who need to be aware within your organization. 4. If you have further distributed the products listed, please identify and promptly notify those recipients of this notice and updated e-IFU. 5. Return the completed Customer Reply Form by Fax or E-Mail to the indicated contact below within 15 calendar days from the date of receipt. 6. Please report any incidents related to this issue to the manufacturer, dealer, or local representative and, if applicable, to the national competent authority, as this is important feedback. 7. (Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.)
Quantity in Commerce1 unit
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FGA
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