KARL STORZ Radel Sterilization Trays recall
KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Why was KARL STORZ Radel Sterilization Trays recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model - UDI-DI/GTIN: 27717A - 4048551089262, 27717B - 4048551089286, 39301A - 4048551156957, 39301C - 4048551157046, 39231XA, 39301C1, 39311A, 39317A. All Lots.
- Product
- KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
- Recalling firm
- Karl Storz Endoscopy
- 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.
- Recall date
- June 28, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)