KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
FDA device recall Z-1981-2023 · posted 2023-06-21 · Open, Classified
Recall details
- Recalling firm
- Karl Storz Endoscopy
- Reason for recall
- 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.
- Action taken
- 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 firm phone number was provided: 800-421-0837
- Root cause
- No Marketing Application
- Status
- Open, Classified
- Product code
- KCT
- Quantity affected
- 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
- Date initiated
- 2023-04-05
- Date posted
- 2023-06-21
- Location
- El Segundo, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Karl Storz Radel Sterilization Trays (K203572) | Karl Storz Endoscopy America, Inc. | 2021-05-07 |