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U.S. Department of Health and Human Services

Class 2 Device Recall KARL STORZ Radel Sterilization Trays

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  Class 2 Device Recall KARL STORZ Radel Sterilization Trays see related information
Date Initiated by Firm April 05, 2023
Date Posted June 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-1981-2023
Recall Event ID 92182
510(K)Number K203572  
Product Classification Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
Product KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Code Information Model - UDI-DI/GTIN: 27717A - 4048551089262, 27717B - 4048551089286, 39301A - 4048551156957, 39301C - 4048551157046, 39231XA, 39301C1, 39311A, 39317A. All Lots.
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy
2151 E Grand Ave
El Segundo CA 90245-5017
For Additional Information Contact
424-218-8201
Manufacturer Reason
for Recall		 Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.
FDA Determined
Cause 2		 No Marketing Application
Action On 4/5/23, correction notices were sent to customers informing them that new instructions for use were available: https://spwebspace.karlstorz.com/sites/RadelTrays/SitePages/Home.aspx 1) Ensure all relevant personnel in your organization review the notice and new Instructions for Use. 2) If you have previously sold or transferred any of the affected trays to a third party, please forward this notice to all such third parties. 3) Complete and return the acknowledgement form to karlstorz5057@sedgwick.com Customers with questions can email karlstorz5057@sedgwick.com. The following recalling firm phone number was provided: 800-421-0837
Quantity in Commerce 4,386
Distribution Worldwide - US Nationwide distribution including in the states of AK, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OR, PA, RI, SC, VA, VT, AL, CO, GU, IA, ID, KY, ME, MN, MT, ND, NE, NJ, NM, OK, PR, SD, TN, UT, WA, WI, WV, WY and the country of CA.
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 = KCT and Original Applicant = Karl Storz Endoscopy America Inc
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