Cook Medical LLC
United Statesfrom the FDA registration address FDA establishment FEI 3005580113
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 21 ongoing
Catalogue
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3005580113
- Address
- 400 DANIELS WAY, Bloomington, IN, 47404
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 1
- 2021 0
- 2022 0
- 2023 1
- 2024 0
- 2025 0
- 2026 0
2023
- 7 Dec 2023 Z-0722-2024 Class II Ongoing 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 degeneration necessitating an additional medical procedure for the patient.
Full distribution text
- 7 Dec 2023 Z-0722-2024 Class II Ongoing 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 degeneration necessitating an additional medical procedure for the patient.
2020
- 16 Dec 2020 Z-0809-2021 Class II Terminated 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 gas flow to the incubation chambers of the Mini Incubator.
Frequently asked questions
How many devices does COOK MEDICAL LLC have in the registry?
The registry currently lists 1 device for COOK MEDICAL LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list COOK MEDICAL LLC's devices?
Among its 1 most recently registered device, COOK MEDICAL LLC has devices listed in FDA 510(k) (1 device).
What risk classes do COOK MEDICAL LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for COOK MEDICAL LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for COOK MEDICAL LLC?
FDA recall records list 2 recalls initiated by COOK MEDICAL LLC, the most recent initiated on 7 Dec 2023. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from COOK MEDICAL LLC in the registry?
The most recently registered devices listed for COOK MEDICAL LLC include Micropuncture Introducer Sets; Micropuncture Pedal Access Sets.