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cryo-GO Vitrification Device - Red (Pack of 10)
IRVINE SCIENTIFIC, LLC · Model 70307-R · UDI-DI 00810195240002
MQK
Prescription
10
510(k) clearances
2
Adverse events
4
Recalls
55
Facilities
Description
cryo-GO Vitrification Device - Red (Pack of 10). A device composed of a body and a cap for use in ART procedures which includes oocytes and embryos cryopreservation by vitrification. The device is to be used with a vitrification and warming protocol.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-04-01 | CooperSurgical, Inc. | Products in this lot may have compromised barrier seals, introducing a risk to sterility. |
| 2014-06-20 | ORIGIO, Inc | Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration |
| 2011-11-28 | ORIGIO HUMAGEN PIPETS INC. | Cryopettes were rupturing during the warming process following vitrification. |
| 2007-05-08 | Humagen Fertility Diagnostics, Inc. | Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated. |
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