Z-2589-2023 Class II Ongoing
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