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U.S. Department of Health and Human Services

Class 2 Device Recall Karl Storz Optical Scissor

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  Class 2 Device Recall Karl Storz Optical Scissor see related information
Date Initiated by Firm February 27, 2024
Date Posted April 03, 2024
Recall Status1 Open3, Classified
Recall Number Z-1473-2024
Recall Event ID 94171
510(K)Number K951343  
Product Classification Laparoscope, gynecologic (and accessories) - Product Code HET
Product Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Code Information UDI: 04048551259788/ All Lots
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy
2151 E Grand Ave
El Segundo CA 90245-5017
For Additional Information Contact Kathy Strange
424-218-8201
Manufacturer Reason
for Recall		 Inadequate reprocessing validation evidence
FDA Determined
Cause 2		 Under Investigation by firm
Action On March 4, 2024, Karl Storz issued a "Urgent: Medical Device Recall" via UPS. Karl Storz asked consignees to take the following actions: 1. Immediately quarantine and discontinue use of associated part numbers listed. 2. Pass on this Urgent Medical Device Recall Notice to all users of the products listed above (Table 1) and all other persons who need to be aware within your organization. 3. If you have or may have distributed the products listed, please identify and promptly notify those recipients, or provide KARL STORZ a list of customers who received/may have received the products listed. 4. 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. 5. Contact your KARL STORZ representative or call KARL STORZ Customer Support to return affected products. For Human Product: 5a. Call Customer Support at 800-421-0837 Option 1 to set up an RMA. 5b. Or call your KARL STORZ representative to assist with setting up an RMA. For Veterinary Product: 5c. Call KSVEA Customer Support at 800-955-7832 Option 1 to set up an RMA. 5d. Or email VetCustomerService@karlstorz.com 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 Commerce 27 units
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HET and Original Applicant = KARL STORZ ENDOSCOPY-AMERICA, INC.
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