Z-2589-2023 Class II Ongoing
FDA device recall Z-2589-2023 was initiated by Karl Storz Endoscopy on July 7, 2023 and is designated Class II. Reason for recall: Flexible intubation endoscopes sterility assurance can not be confirmed. The recall status is ongoing. Affected quantity: 218 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 27, 2023
- Initiation Date
- July 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 218 units
Product Description
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Reason for Recall
Flexible intubation endoscopes sterility assurance can not be confirmed.
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MEX, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada.
Code Information
UDI: 04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461