Fujifilm Irvine Scientific, Inc. Recall 91557
Description: Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Fujifilm Irvine Scientific, Inc. Recall 91557 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1314-2023 |
| Event ID | 91557 |
| Event Description | Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305 |
| Product Type | Devices |
| Distribution | 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 |
| Quantity | 15,131 bottles |
| Recall Reason | Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products. |
| Device Classification | 20230405 |
| Device Code Info | UDI-Di Code: 08937270029305TH Catalog Number / Lot Numbers: 9305-100ml / 0000011351, 9305-500ml / 0000011367, 9305-100ml / 0000015999, 9305-500ml / 0000016001 |
| Center Classification Date | 20230330 |
| Recall Initiation Date | 20230116 |
| Recalling Firm | Fujifilm Irvine Scientific, Inc. |
| Initial Notification | Letter |
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