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Open, Classified

Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS); 39301BS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 5MM X 35CM); 39301C1S/RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE & LT CABLE); 39301CS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPE 10MM X 31CM); 39301DS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39301HCTS/CAMERA TRAY (STERRAD, STANDARD CAMERA HEADS); 39301PHTS/CAMERA TRAY (STERRAD, PENDULUM/INLINE CAM HEADS); 39305C1S/BASKET-STYLE RIGID TELESCOPE TRAY (UDEL, 1 RIGID SCOPE 4MM X 30CM); 39305C2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39305L1S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE); 39305L2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39311AS/RIGID TELESCOPE TRAY (STERRAD, 4 RIGID SCOPES & LT CABLE); 39311BS/RIGID TELESCOPE TRAY (STERRAD, TWO LAP SCOPES/CABLE); 39314FS/RIGID TELESCOPE TRAY (STERRAD, FOUR LAP SCOPES/CABLE); 39401AS/FLEXIBLE ENDOSCOPE TRAY (UP TO 39CM); 39402AS/FLEXIBLE ENDOSCOPE TRAY (FIBERSCOPES); 39403AS/FLEXIBLE ENDOSCOPE TRAY (CCD VIDESCOPES); 39406AS/FLEXIBLE ENDOSCOPE TRAY (CMOS VIDEOSCOPES)

FDA Recall Z-0442-2022 · Posted None

Recalling FirmKarl Storz Endoscopy
Recall StatusOpen, Classified
Product CodeKCT
Date Initiated2021-10-15
Product Quantity71892

Reason for Recall

To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality.

Firm Action

On 10/15/21 correction notices were mailed to customers. Customers were asked to do the following: 1) Ensure all personnel in your organization review this letter and the current instructions for use. If you have previously sold or transferred affected devices to a third party, please forward this notice to all such third parties. 2) Discard any prior versions of the instructions for use. 3) Complete and return the acknowledgment form. Customers with medical or safety-related inquiries can contact Medical Affairs at 1-800-649-8852 or [email protected]. Customers with questions about the correction communication are encouraged to call 1-866-913-0667 or email [email protected].

Root Cause

Device Design

Distribution Pattern

US: AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: Canada, Venezuela, Barbados, GUAM, Puerto Rico, Mexico, Northern Mariana Islands, Trinidad & Tobago, Germany, Cayman Islands, Philippines, Japan, Dominican Republic, Panama, Bahamas, Ecuador, Suriname, American Virgin Islands, British Virgin Islands, Belize, Curacao, The Bahamas, Brazil, South Korea, Bermuda

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K201945KARL STORZ UDEL Sterilization TraysKarl Storz Endoscopy America, Inc. · 2021-02-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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