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STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND WHITE FLEXIBLE ROD / BLISTER 5X15

CRYO BIO SYSTEM · Model 1 · UDI-DI 03661532000486

510(k) clearances

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2023-12-07	Cook Medical Llc	The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degenerat
2022-08-12	CooperSurgical, Inc.	There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the steri
2022-08-12	CooperSurgical, Inc.	There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the steri
2020-12-16	Cook Medical Llc	A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding
2019-09-05	CooperSurgical, Inc.	The touchpad may not work properly after cleaning.
2018-03-22	Cook Inc.	Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to
2018-03-22	Cook Inc.	Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to
2018-01-12	Cook Inc.	The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex l
2018-01-12	Cook Inc.	The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex l

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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.