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CryotopUS-scoop(W)
KITAZATO CORPORATION · Model CryotopUS-scoop(W) · UDI-DI 04582231462865
MQK
Prescription
1
510(k) clearances
2
Adverse events
4
Recalls
55
Facilities
Description
Cryopreservation storage devices that are intended for use in vitrificationprocedures to contain and maintain human oocytes (MII) and embryos.
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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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.