FDA Device Intelligence
HomeCRYO BIO SYSTEM › BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - RED

BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - RED

CRYO BIO SYSTEM · Model 1 · UDI-DI 03661532002961

MQK
10
510(k) clearances
2
Adverse events
4
Recalls
55
Facilities

Recalls

DateFirmReason
2022-04-01CooperSurgical, Inc.Products in this lot may have compromised barrier seals, introducing a risk to sterility.
2014-06-20ORIGIO, IncIdentification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration
2011-11-28ORIGIO HUMAGEN PIPETS INC.Cryopettes were rupturing during the warming process following vitrification.
2007-05-08Humagen Fertility Diagnostics, Inc.Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data 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.