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U.S. Department of Health and Human Services

Class 2 Device Recall LASER Application Instrument

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  Class 2 Device Recall LASER Application Instrument see related information
Date Initiated by Firm April 01, 2024
Date Posted May 13, 2024
Recall Status1 Open3, Classified
Recall Number Z-1809-2024
Recall Event ID 94389
510(K)Number K942786  
Product Classification Powered laser surgical instrument - Product Code GEX
Product LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Code Information All lots. REF/UDI-DI: 8694/04048551216392, 461000/04048551164860
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy
2151 E Grand Ave
El Segundo CA 90245-5017
For Additional Information Contact Kathy Strange
774-284-1736
Manufacturer Reason
for Recall		 Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection.
FDA Determined
Cause 2		 Device Design
Action On 4/1/24, recall notices were mailed to representatives for medical product safety, users, operators, distributors who were asked to do the following: 1) Quarantine and discontinue use of affected devices. 2) Pass on the recall notice to all users of the affected devices and to 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 the recalling firm a list of customers who received/may have received the products listed. 4) Complete and return the customer reply form via email to karlstorz4835@sedgwick.com 5) If you have product to return contact the firm at the following phone numbers: For Human Product Telephone: 800-421-0837 Option 1 For Vet Product Telephone: 800-955-7832 Option 1 The firm has placed all affected product on hold and has ceased the distribution of the affected product in the U.S. until further notice. For all other questions regarding this communication, please send an email to KSEAProductLabeling@karlstorz.com
Quantity in Commerce 85
Distribution Worldwide distribution - US Nationwide in the states of OH, CA, FL, MA, TX, KY, WI, MI, MN, AR, NE, IL, NY, HI and the country of Argentina.
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 = GEX and Original Applicant = KARL STORZ ENDOSCOPY-AMERICA, INC.
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