DEWIN
DonneVie Medical Technology(Shanghai)Co.Ltd · Model 9341 · UDI-DI 06972962312443
MQL
Prescription
1
510(k) clearances
24
Adverse events
15
Recalls
30
Facilities
Description
Dewin Fertilization Medium is intended for use during vitro fertilization (IVF) procedures and culture to the two pronuclei (zygote) stage of development. Dewin Fertilization Medium is also intended for washing and handling sperm and collected oocytes after aspiration prior to IVF procedures. Dewin Fertilization Medium is not intended for use in intrauterine insemination procedures
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.