Intermed, Inc.
United StatesFDA applicant, unverified FDA FEI 3000209941
Part of Inter.med
- Devices
- 28
- Registrations
- FDA
- FDA recalls
- 81 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Intermed, Inc. makes
Intermed, Inc. manufactures a range of medical devices including Foley catheters, irrigation trays, non-sterile parenteral supply kits, sterile water and saline bags, disposable urinary leg bags, percutaneous sheath introducer trays, latex extension tubes with connectors, central venous catheter trays, suction catheter trays, acute hemodialysis trays, urinary drainage bags, and dressing change trays.
These devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Search and filter all 28 devicesCompany details
- FDA FEI number
- 3000209941
- Address
- 2200 South St, Racine, WI, 53404
FDA recalls
FDA recall records list 8 recalls initiated by Intermed, Inc., the earliest on 2019-06-27 and the most recent on 2026-05-27. By recorded status: 1 ongoing and 7 terminated. The reasons filed fall into these groups: packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 7
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 1
2026
- 27 May 2026 Z-2400-2026 Class II Ongoing Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to induce vomiting.
2019
- 27 Jun 2019 Z-0011-2020 Class II Terminated The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
- 27 Jun 2019 Z-0012-2020 Class II Terminated The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
- 27 Jun 2019 Z-0013-2020 Class II Terminated The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
- 27 Jun 2019 Z-0014-2020 Class II Terminated The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
- 27 Jun 2019 Z-0015-2020 Class II Terminated The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
- 27 Jun 2019 Z-0016-2020 Class II Terminated The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
- 27 Jun 2019 Z-0017-2020 Class II Terminated The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
Frequently asked questions
How many devices does Intermed, Inc. have in the registry?
The registry currently lists 28 devices for Intermed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intermed, Inc.'s devices?
Among its 28 most recently registered devices, Intermed, Inc. has devices listed in FDA 510(k) (28 devices).
What risk classes do Intermed, Inc.'s devices fall under?
Among its 28 most recently registered devices, the classes recorded for Intermed, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Intermed, Inc.?
FDA recall records list 8 recalls initiated by Intermed, Inc., the most recent initiated on 2026-05-27. 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 Intermed, Inc. in the registry?
The most recently registered devices listed for Intermed, Inc. include FOLEY CATHETERS, IRRIGATION TRAY, NON STERILE PARENTERAL SUPPLY KIT and ReminGel.