Data / Medical devices / United States / Excelsior Medical LLC
Excelsior Medical LLC: FDA-registered device maker in Neptune, NJ, United States, 5 510(k) clearances
Excelsior Medical LLC is registered with the FDA (registration 2027791) in Neptune, NJ, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 15, 2019. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2027791
- FEI number
- 1000122362
- Address
- 1933 Heck Ave, Neptune, NJ, United States, 07753
- Owner or operator
- Medline Industries, LP (9000300)
- Roles
- Manufacturer
- First device listed
- January 8, 2009
- Registered through
- 2027
- Brand names listed
- 0.9% Sodium Chloride Injection, USP, 0.9% Sodium Chloride Injection, USP, Pre-Filled COP Syringe, Heparin Lock Flush, USP, Saline FLush For Sterile Field, Saline Flush Syringe, SwabFlush
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cap, Device Disinfectant | QBP | 2 | Manufacturer | accessdata.fda.gov |
| Heparin, Vascular Access Flush | NZW | 2 | Manufacturer | accessdata.fda.gov |
| Saline, Vascular Access Flush | NGT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 15, 2019 | K191378 | 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe | NGT | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| June 21, 2018 | K173348 | 0.9% Sodium Chloride Injection, USP | NGT | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| November 14, 2014 | K133446 | HEPARIN LOCK / FLUSH SYRINGES | NZW | Substantially Equivalent | Excelsior Medical Corporation | accessdata.fda.gov |
| December 24, 2013 | K130975 | SWABCAP AND SWABFLUSH | QBP | Substantially Equivalent | Excelsior Medical Corp. | accessdata.fda.gov |
| December 18, 2008 | K082837 | STERILE FIELD SALINE PRE-FILLED SYRINGE(S) | NGT | Substantially Equivalent | Excelsior Medical Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 28, 2016 | 74045 | Class II | Terminated | Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only. | 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. | accessdata.fda.gov |
| June 5, 2014 | 68573 | Class II | Terminated | Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer | 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. | accessdata.fda.gov |
| May 7, 2012 | 61823 | Not yet classified | Terminated | Heparin Lock Flush Solution 100 Unit/mL, USP 3 ml, 4 ml, 5mL, 6 ml fill in a 10 ml Flush Syringe ZR Excelsior Medical Neptune, NJ 07753 Made in USA NDC 63807060055. Used to maintain patency of vascular access devices des | 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. | accessdata.fda.gov |
| September 2, 2010 | 56685 | Not yet classified | Terminated | Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use | 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 | accessdata.fda.gov |
| January 13, 2009 | 50848 | Not yet classified | Terminated | Sterile Field Saline Flush; 0.9% Sodium Chloride Injection, USP; Rx Only; Single Use. Excelsior Medical, Neptune, NJ. This product is used for the flushing of venous access devices and intravenous tubing. | 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. | accessdata.fda.gov |
| April 24, 2006 | 35960 | Not yet classified | Terminated | 0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex. | The syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes. | accessdata.fda.gov |
| March 21, 2006 | 34961 | Not yet classified | Terminated | ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured by Excelsior Medical Corporation, Neptune, NJ. | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Saline, Vascular Access Flush
- All makers of Heparin, Vascular Access Flush
- All makers of Cap, Device Disinfectant
Updated September 15, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.