Vit Kit-Freeze is intended for use in assisted recall
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes…
Why was Vit Kit-Freeze is intended for use in assisted recalled?
Due to a component in kit being labeled with the incorrect Expiration Date
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog number: 90133-DSOC Kit- Vitrification Freeze kit: Which contained VS Vitrification solution, Lot/Unit numbers: 90132210403; UDI # 00893727002811; 9 x1 mL Vitrification Solution, VS, Catalog #0132 and 9x1mL. Equilibration Solution, ES Catalog 90131
- Product
- Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes…
- Recalling firm
- Fujifilm Irvine Scientific, Inc.
- Quantity
- 677 units or kits of 90133-DSOC210605 (9 x 1ml per kit); 595 kits in U.S. and 82 kits OUS
- Distribution
- Worldwide Distribution: U.S. (nationwide) to states of: AL, AK, AZ, CA, CT, DE, FL, ID, IL, IN, ND, NC, NV, NY, NJ, NE, OH, OK, OR, PA, SC, SD, MA, MS, MI, MO, MD, MN, TN, TX, UT, VA, VT, WI, WV and OUS (international) to countries of: Brazil, EU, Canada, India, South Korea, and Singapore.
- Recall date
- November 24, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)