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Metal Tray, 178 x 135 x 37 mm, REF: 11580A recallZ-1991-2023 · Karl Storz Endoscopy · initiated Apr 6, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Karl Storz Endoscopy or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: No Marketing Application

What the company is doing

On 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 [email protected] Customers correction-related questions can contact [email protected] or 888-943-5128. Customers with device-related questions can call 800-421-0837

Recall details

Recall number
Z-1991-2023
Status
Open, Classified
Initiated by the company
Apr 6, 2023
Posted by the FDA
Jun 21, 2023
Recalling firm
Karl Storz Endoscopy
Quantity
4,933
Product code
KCT
FDA submissions
K203198
Distribution
Worldwide - 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.

Product description

Metal 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 (models, lots, serial numbers)

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.

Devices named in this recall

16 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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