Z-1981-2023 Class II Ongoing
FDA device recall Z-1981-2023 was initiated by Karl Storz Endoscopy on April 5, 2023 and is designated Class II. 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 als… The recall status is ongoing. Affected quantity: 4,386.
Recall Details
- Product Type
- Devices
- Report Date
- June 28, 2023
- Initiation Date
- April 5, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,386
Product Description
KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
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.
Distribution Pattern
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.
Code Information
Model - UDI-DI/GTIN: 27717A - 4048551089262, 27717B - 4048551089286, 39301A - 4048551156957, 39301C - 4048551157046, 39231XA, 39301C1, 39311A, 39317A. All Lots.