Z-1314-2023 Class II Ongoing

Recalled by Fujifilm Irvine Scientific, Inc. — Santa Ana, CA

Recall Details

Product Type
Devices
Report Date
April 5, 2023
Initiation Date
January 16, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15,131 bottles

Product Description

Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305

Reason for Recall

Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.

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

Code Information

UDI-Di Code: 08937270029305TH Catalog Number / Lot Numbers: 9305-100ml / 0000011351, 9305-500ml / 0000011367, 9305-100ml / 0000015999, 9305-500ml / 0000016001