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U.S. Department of Health and Human Services

Class 2 Device Recall KARL STORZ Metal Sterilization Trays

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 Class 2 Device Recall KARL STORZ Metal Sterilization Trayssee related information
Date Initiated by FirmApril 06, 2023
Date PostedJune 21, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1991-2023
Recall Event ID 92244
510(K)NumberK203198 
Product Classification Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
ProductMetal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Metal Tray, 275 x 175 x 37 mm, REF: 11580D; Wire Tray f. Cleaning, 290x60x52mm, REF: 39501A1; Wire Tray f. Cleaning, 352 x 125 x 54 mm, REF: 39501A2; Wire Tray f. Cleaning, 487 x 125 x 54 mm, REF: 39501B2; Wire Tray for ENDOCAMELEON, REF: 39501BEC; Tray, with lid, 670x80x52mm, REF: 39501C; Wire Tray for ENDOCAMELEON, long version, REF: 39501CEC; Wire Tray Retromolar Intub. Endoscope, REF: 39501F; Wire basket for c-mac videolaryngoscope, REF: 39501LC2; Tray, URS, 644 x 150 x 80 mm, REF: 39501X; Wire Tray, URS, REF: 39501XK; Wire tray PECD, REF: 39501XP; Tray, paranasal sinus shaver system, REF: 39550A
Code Information REF/UDI-DI: 11580A/ 04048551051801; 11580B/ 04048551051818; 11580C/ 04048551051825; 11580D/ 04048551051832; 39501A1/ 04048551157619; 39501A2/ 04048551157626; 39501B2/ 04048551157657; 39501BEC/ 04048551241400; 39501C/ 04048551157671; 39501CEC/ 04048551254158; 39501F/ 04048551157695; 39501LC2/ 04048551273432; 39501X/ 04048551157756; 39501XK/ 04048551157763; 39501XP/ 04048551157770; 39550A/ 04048551157879. All lots.
FEI Number 3007475226
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		Metal 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
ActionOn 4/6/23, correction notices were distributed to customers who were informed the following: Affected metal trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycles (132C for 4 minutes with a 20-minute dry time). When used in conjunction with an FDA-cleared sterilization wrap, sterility of the enclosed medical device is maintained until used. The system has been validated with devices with working channels greater-than-or-equal-to 0.2 mm and a maximum length of 240 mm. 1) Ensure that all relevant personnel in your organization review this letter, including the new Instructions for Use for the metal trays: following: https://spwebspace.karlstorz.com/sites/MetalTrays/SitePages/Home.aspx 2) If you have previously sold or transferred any of the affected metal trays to a third party, please forward this notice to all such third parties. 3) Complete and return the Acknowledgment Form to karlstorz5983@sedgwick.com Customers correction-related questions can contact karlstorz5983@sedgwick.com or 888-943-5128. Customers with device-related questions can call 800-421-0837
Quantity in Commerce4,933
DistributionWorldwide - US Nationwide distribution including in the states of IN, MS, MN, AZ, FL, IL, CA, AK, NY, VA, TX, PA, LA, ND, AS, MD, NH, SC, AR, GA, NJ, NC, WA, WI, SD, TN, KY, AL, OK, MO, MA, MI, CT, UT, WY, CO, OH, DC, DE, NM, MT, ME, OR, PA, WV, IA, NE, HI, KS, ID, NV, RI, VT, GU and the country of CA.
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 = KCT
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