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U.S. Department of Health and Human Services

Class 2 Device Recall Injection Needle, REF: 25207

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  Class 2 Device Recall Injection Needle, REF: 25207 see related information
Date Initiated by Firm October 24, 2023
Date Posted December 18, 2023
Recall Status1 Open3, Classified
Recall Number Z-0571-2024
Recall Event ID 93328
510(K)Number K945209  
Product Classification Proctoscope - Product Code GCF
Product Injection Needle, REF: 25207
Code Information UDI-DI: 04048551085776. All lot numbers
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		 The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
FDA Determined
Cause 2		 Device Design
Action On 10/24/23, recall notices were mailed to representatives for medical product safety, users, operators, distributors who were asked to do the following: 1) Discontinue use of all affected Injection Needles. 2) Pass on the Recall Notice to all users of the affected products 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 the recalling firm with a list of customers who received/may have received the products listed. 4) Contact Customer Support to arrange for the return of affected devices by calling 800-421-0837. 5) Return the completed Customer Reply Form via email to karlstorz5190@sedgwick.com For all other questions regarding this communication, please send an email to KSEAProductLabeling@karlstorz.com
Quantity in Commerce 1
Distribution US: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI, VA, IN, IA, AR, TX, WV, MD, MN, GA, MA, NM, VT, AK, OR, ID, LA, KS, DC, KY, HI OUS: Mexica, Canada, Germany
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 = GCF and Original Applicant = KARL STORZ ENDOSCOPY-AMERICA, INC.
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