Device product
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Z-1314-2023
Product summary
- Event
- Event 91557
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15,131 bottles
- Official record key
device-enforcement:Z-1314-2023
Official wording
Reason: Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
Code information: UDI-Di Code: 08937270029305TH Catalog Number / Lot Numbers: 9305-100ml / 0000011351, 9305-500ml / 0000011367, 9305-100ml / 0000015999, 9305-500ml / 0000016001
Distribution pattern: U.S.: AZ, AR, CA, CT, DC, FL, HI, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WI and WV. O.U.S.: India, Israel, Japan, Malaysia, Mexico, South Korea, South Africa, Thailand, Vietnam, Brazil, Bosnia, Argentina, Netherlands, and United Kingdom
Derived failure modes
-
Unknown
Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.