Z-1067-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- April 1, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- All Serial Numbers manufactured/distributed since January 2018.
Product Description
11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018);
Reason for Recall
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Distribution Pattern
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA,WI, WV, and WY. O.U.S.: Mexico, Lebanon, and South Korea
Code Information
11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551402573; 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016) UDI Code: 4048551226353; 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551402504; 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551226377; 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551226438; All Serial Numbers manufactured/distributed since January 2018.