V-VITWARM
VITROMED GmbH · Model V-TS-KIT · UDI-DI 04260650070341
Description
V VITWARM is a ready-to-use kit to thaw human oocytes and embryos (up to blastocyst stage) which are cryopreserved. Subsequently, the thawed oocytes and embryos can be used in Assisted Reproduction Technology (ART) processes. There are in total 4 vials of pink solutions in the package: - 2 vials of Thawing Solution (TS), with red caps and labels. - 1 vial of Diluent Solution (DS), with a yellow cap and label. - 1 vial of Washing Solution (WS), with a white cap and label. V-VITWARM is intended for use in the thawing of vitrified of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-16 | CooperSurgical, Inc. | Low concentration of sodium pyruvate in the wash could compromise gamete development |
| 2024-02-16 | CooperSurgical, Inc. | Low concentration of sodium pyruvate in the wash could compromise gamete development |
| 2024-02-16 | CooperSurgical, Inc. | Low concentration of sodium pyruvate in the wash could compromise gamete development |
| 2023-12-20 | CooperSurgical, Inc. | The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage. |
| 2023-11-02 | Fujifilm Irvine Scientific, Inc. | The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) b |
| 2023-02-13 | CooperSurgical, Inc. | It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source |
| 2023-01-16 | Fujifilm Irvine Scientific, Inc. | Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products. |
| 2022-12-15 | CooperSurgical, Inc. | The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo. |
| 2022-06-13 | CooperSurgical, Inc. | There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct |
| 2021-09-08 | Fujifilm Irvine Scientific, Inc. | Due to a component in kit being labeled with the incorrect Expiration Date |
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