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U.S. Department of Health and Human Services

Class 2 Device Recall FujiFilm Oil for Embryo Culture

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  Class 2 Device Recall FujiFilm Oil for Embryo Culture see related information
Date Initiated by Firm January 16, 2023
Date Posted April 01, 2023
Recall Status1 Open3, Classified
Recall Number Z-1314-2023
Recall Event ID 91557
510(K)Number K011938  
Product Classification Media, reproductive - Product Code MQL
Product Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Code Information UDI-Di Code: 08937270029305TH Catalog Number / Lot Numbers: 9305-100ml / 0000011351, 9305-500ml / 0000011367, 9305-100ml / 0000015999, 9305-500ml / 0000016001
Recalling Firm/
Manufacturer		 Fujifilm Irvine Scientific, Inc.
2511 Daimler St
Santa Ana CA 92705-5533
For Additional Information Contact Melissa Gomez
949-261-7800 Ext. 457
Manufacturer Reason
for Recall		 Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 01/16/2023, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that, the firm has received complaints of reduced blastocyst development, including complete degradation in some cases, during culture of human embryos. Additionally, some clinics performed Human Sperm Survival Assay (HSSA), as part of incoming confirmatory Quality Control testing, and reported low sperm motility. Customers are instructed to: 1. Immediately stop using the product; 2. Quarantine any remaining product in inventory; 3. Return or destroy the product; 4. Complete and return the enclosed MEDICAL DEVICE RETURN RESPONSE FORM; and 5. Email the completed MEDICAL DEVICE RETURN RESPONSE FORM to fisira@fujifilm.com by January 23, 2023. For questions, contact: Customer Service Manager, Medical Business: - Toll free in the US: 1.800.577.6097 - Phone: 1.949.261.7800 x457 - Email: Melissa Gomez, fisitmrequest@fujifilm.com
Quantity in Commerce 15,131 bottles
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MQL and Original Applicant = IRVINE SCIENTIFIC SALES CO., INC.
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