Alaris Medical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 16
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Alaris Medical Systems, Inc. makes
The company manufactures infusion pumps, including variable pressure syringe pumps and modular syringe pump systems like the Medley 8110, as well as infusion administration sets for medical use. It also produces patient monitoring devices such as the A-Line AEP monitor and Medley modules for capnography (ETCO₂), pulse oximetry (SpO₂), and patient-controlled analgesia (PCA). Additional products include bar-code-enabled infusion systems, single-dose dispensing pins, and peripheral intravenous catheters like the King of Hearts Express II.
These devices are classified under Class II in the U.S. regulatory framework and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Search and filter all 16 devicesFDA recalls
FDA recall records list 1 recall initiated by Alaris Medical Systems, Inc., initiated on 2004-11-10. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 10 Nov 2004 Z-0568-05 Unclassified (pre-2012) Terminated The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. To date there have been complaints from three (3) different customer locations.
Frequently asked questions
How many devices does Alaris Medical Systems, Inc. have in the registry?
The registry currently lists 16 devices for Alaris Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alaris Medical Systems, Inc.'s devices?
Among its 16 most recently registered devices, Alaris Medical Systems, Inc. has devices listed in FDA 510(k) (16 devices).
What risk classes do Alaris Medical Systems, Inc.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for Alaris Medical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Alaris Medical Systems, Inc.?
FDA recall records list 1 recall initiated by Alaris Medical Systems, Inc., the most recent initiated on 10 Nov 2004. 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 Alaris Medical Systems, Inc. in the registry?
The most recently registered devices listed for Alaris Medical Systems, Inc. include VARIABLE PRESSURE SYRINGE PUMP, MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110, A-LINE AEP MONITOR and MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300.