Recall Z-0442-2022 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Karl Storz Endoscopy
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); 39301
| Date | Oct 15, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| 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 medicalaffairs@karlstorz.com. Customers with questions about |
| Quantity | 71892 |
| Distribution | 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, T |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201945 | KARL STORZ UDEL Sterilization Trays Karl Storz Endoscopy America, Inc., Feb 25, 2021 |