Horizon Medical Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 16
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Horizon Medical Products, Inc. makes
Horizon Medical Products, Inc. manufactures vascular access ports, hemodialysis catheters, and infusion systems. Their portfolio includes titanium and polysulfone ports (e.g., TITANIUM LOW PROFILE PORT, DUAL TITANIUM PORT), central venous catheters (e.g., LIFEVALVE CATHETER, SUPER C CHRONIC CATHETER), and vascular access systems (e.g., TRIUMPH VTX, LIFEPORT VTX ACCESS SYSTEM). Modifications to existing ports (e.g., MODIFICATION TO VORTEX MP) and safety infusion sets (e.g., LIFEGUARD SAFETY INFUSION SET) are also part of their offerings.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company operates within the United States.
Catalogue
Search and filter all 16 devicesFDA recalls
FDA recall records list 3 recalls initiated by Horizon Medical Products, Inc., the earliest on 2004-05-28 and the most recent on 2004-09-20. By recorded status: 3 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 20 Sep 2004 Z-0256-05 Unclassified (pre-2012) Terminated The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer.
- 28 May 2004 Z-1029-04 Unclassified (pre-2012) Terminated The products have a potential defective seal that closes the product's OUTER POUCH. The surface of the INNER TRAY may no longer be sterile.
- 28 May 2004 Z-1030-04 Unclassified (pre-2012) Terminated The products have a potential defective seal that closes the product's OUTER POUCH. The surface of the INNER TRAY may no longer be sterile.
Frequently asked questions
How many devices does Horizon Medical Products, Inc. have in the registry?
The registry currently lists 16 devices for Horizon Medical Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Horizon Medical Products, Inc.'s devices?
Among its 16 most recently registered devices, Horizon Medical Products, Inc. has devices listed in FDA 510(k) (16 devices).
What risk classes do Horizon Medical Products, Inc.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for Horizon Medical Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Horizon Medical Products, Inc.?
FDA recall records list 3 recalls initiated by Horizon Medical Products, Inc., the most recent initiated on 20 Sep 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 Horizon Medical Products, Inc. in the registry?
The most recently registered devices listed for Horizon Medical Products, Inc. include HMP TITANIUM LOW PROFILE PORT, TRIUMPH VTX WITH LIFEVALVE CATHETER, LIFEVALVE CENTRAL VENOUS CATHTER and HMP DUAL TITANIUM PORT.