Recall Z-1981-2023 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Karl Storz Endoscopy
KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
| Date | Jun 21, 2023 (initiated Apr 5, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 fir |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203572 | Karl Storz Radel Sterilization Trays Karl Storz Endoscopy America, Inc., May 7, 2021 |