Excelsior Medical LLC
Neptune, NJ, US
EXCELSIOR MEDICAL LLC appears in FDA device records in Neptune, NJ. FDA records list 11 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Excelsior Medical LLC between 1995 and 2014. The busiest year on record is 2014, with 2. The most recent is 2014, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1996 | 1 |
| 2003 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K142620 | 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 | NGT | Substantially Equivalent | |
| K133446 | HEPARIN LOCK / FLUSH SYRINGES | NZW | Substantially Equivalent | |
| K130975 | SWABCAP AND SWABFLUSH | QBP | Substantially Equivalent | |
| K101270 | SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 | NGT | Substantially Equivalent | |
| K083508 | SWABCAP | QBP | Substantially Equivalent | |
| K082837 | STERILE FIELD SALINE PRE-FILLED SYRINGE(S) | NGT | Substantially Equivalent | |
| K061497 | SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML | NZW | Substantially Equivalent | |
| K053120 | STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES | FOZ | Substantially Equivalent | |
| K023740 | SYREX PRE-FILLED SYRINGE | NZW | Substantially Equivalent | |
| K962938 | EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) | FOZ | Substantially Equivalent | |
| K942349 | MICROBORE EXTENSION SET | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2027791 | 1000122362 | EXCELSIOR MEDICAL LLC | 1933 Heck Ave, NEPTUNE, NJ 07753 US | 2026 | |
| 3008518459 | 3008518459 | EXCELSIOR MEDICAL LLC | 317 Fairfield Road, Freehold, NJ 07728 US | 2026 | |
| 3036706541 | 3036706541 | EXCELSIOR MEDICAL LLC | 1470 Shafto Road, Tinton Falls, NJ 07712 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1989-2016 | 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. | Class II | Terminated | |
| Z-2070-2014 | 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. | Class II | Terminated | |
| Z-1707-2012 | 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 (800) 487-4276 Made in USA NDC 63807060055. Used to maintain patency of vascular access devices designed for intermittent infusion therapy. Export product for sale in Colombia are used for locking hemodialysis catheters, for heparinization of extracorporeal systems, in hemodialysis, and for peritoneal dialysis. | 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. | Terminated | ||
| Z-0035-2011 | 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 | Terminated | ||
| Z-0973-2009 | 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. | Terminated | ||
| Z-0044-2007 | 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. | Terminated | ||
| Z-0870-06 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain