Excelsior Medical LLC
United Statesfrom the FDA registration address FDA establishment FEI 3008518459
- Devices
- 11
- Registrations
- FDA
- FDA recalls
- 7
Catalogue
Search and filter all 11 devicesCompany details
- FDA FEI number
- 3008518459
- Address
- 317 Fairfield Road, Freehold, NJ, 07728
FDA recalls
2016
- 28 Apr 2016 Z-1989-2016 Class II Terminated Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for heparin potency.
2014
- 5 Jun 2014 Z-2070-2014 Class II Terminated There is a potential for a leak. A molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another.
2012
- 7 May 2012 Z-1707-2012 Not yet classified Terminated Some lots of Heparin Lock Flush, USP Syringes (3 mL fill in 10 ml syringe, 4 mL fill in 10 ml syringe, 5 mL fill in 10 ml and 6 ml in 10 ml syringe), failed Anti-Factor IIa assay for potency.
2010
- 2 Sep 2010 Z-0035-2011 Unclassified (pre-2012) Terminated There is the potential for a dimensional issue in 6 ml syringe products, codes E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, S5, to cause leakage and.or loss of sterility
2009
- 13 Jan 2009 Z-0973-2009 Unclassified (pre-2012) Terminated Sterility Issue: There is the possibility that the affected lots have pouches that were not sealed properly and could potentially compromise the external sterility of the syringes.
2006
- 24 Apr 2006 Z-0044-2007 Unclassified (pre-2012) Terminated The syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes.
- 21 Mar 2006 Z-0870-06 Unclassified (pre-2012) Terminated Potential for alarm failure when the 140 pump completes infusion and/or the pump encounters a mid-infusion occlusion, when used in the 140 mode with a 140cc syringe. The ESP Pump works correctly when used in 60 mode with a 60cc syringe or smaller.
Frequently asked questions
How many devices does EXCELSIOR MEDICAL LLC have in the registry?
The registry currently lists 11 devices for EXCELSIOR MEDICAL LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list EXCELSIOR MEDICAL LLC's devices?
Among its 11 most recently registered devices, EXCELSIOR MEDICAL LLC has devices listed in FDA 510(k) (11 devices).
What risk classes do EXCELSIOR MEDICAL LLC's devices fall under?
Among its 11 most recently registered devices, the classes recorded for EXCELSIOR MEDICAL LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for EXCELSIOR MEDICAL LLC?
FDA recall records list 7 recalls initiated by EXCELSIOR MEDICAL LLC, the most recent initiated on 2016-04-28. 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 EXCELSIOR MEDICAL LLC in the registry?
The most recently registered devices listed for EXCELSIOR MEDICAL LLC include MICROBORE EXTENSION SET, 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe, SWABCAP and SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML.