Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Summary
The FDA issued a Class II for Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305 by Fujifilm Irvine Scientific, Inc.. Reason: Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products..
Details
Source
Device Recall
External ID
Z-1314-2023
Action Date
2023-04-05
Status
Ongoing
Category
device
Product Description
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Lot/Code Info: UDI-Di Code: 08937270029305TH Catalog Number / Lot Numbers: 9305-100ml / 0000011351, 9305-500ml / 0000011367, 9305-100ml / 0000015999, 9305-500ml / 0000016001
Quantity Affected: 15,131 bottles
Reason for Recall
Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-16
Company
Santa Ana, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Fujifilm Irvine Scientific, Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fujifilm Irvine Scientific, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fujifilm Irvine Scientific, Inc. have FDA actions?
Fujifilm Irvine Scientific, Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1314-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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