Panels › General Hospital › Product code NZW · Class 2
Heparin, Vascular Access Flush
Regulation 880.5200
0510(k)s in 12 months (7 all time)
0recalls in 12 months (44 all time)
27recalls that name a 510(k)
Top companies in NZW
| Company | 510(k)s | Recalls |
|---|---|---|
| Vygon Corporation | 0 | 12 |
| Baxter Healthcare Corp. | 0 | 10 |
| Covidien LP | 0 | 9 |
| Medefil, Inc. | 1 | 7 |
| Excelsior Medical Corp. | 3 | 2 |
| App Pharmaceuticals, LLC | 1 | 2 |
| Becton, Dickinson & CO | 1 | 0 |
| Becton, Dickinson and Company | 1 | 0 |
| Fresenius Kabi USA, LLC | 0 | 1 |
| Mckesson Medical-Surgical Inc. Corporate Office | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL Fill in 10 mL Syringe
Model Number: 513604 Open, Classified |
NZW | K133446 |
| Jun 14, 2016 | Excelsior Medical Corp Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only. Terminated |
NZW | K023740 |
| Jan 29, 2015 | Fresenius Kabi USA, LLC HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710 Terminated |
NZW | K092938 |
| Mar 6, 2014 | Medefil Incorporated Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe. Terminated |
NZW | K092491 |
| Jun 19, 2012 | App Pharmaceuticals Llc HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only
To maintain patency of an indwelling venipunc Terminated |
NZW | None listed |
| Jun 19, 2012 | App Pharmaceuticals Llc HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/m Terminated |
NZW | None listed |
| Jun 13, 2012 | Vygon Corporation Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY
Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated |
NZW | K061497 |
| Jun 13, 2012 | Vygon Corporation Churchill Medical Systems, Inc. DRESSING CHANGE KIT
Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated |
NZW | K061497 |
| Jun 13, 2012 | Vygon Corporation Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit
Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated |
NZW | K061497 |
| Jun 13, 2012 | Vygon Corporation Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit
Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated |
NZW | K061497 |
| Jun 13, 2012 | Vygon Corporation Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit
Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated |
NZW | K061497 |
| Jun 13, 2012 | Vygon Corporation Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit
Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated |
NZW | K061497 |
| Jun 13, 2012 | Vygon Corporation Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit
Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens Terminated |
NZW | K061497 |
| Jun 13, 2012 | Vygon Corporation Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only
Prefilled syringes are used to maintain the patency of indwelling catheter Terminated |
NZW | K061497 |
| Jun 13, 2012 | Vygon Corporation Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only
Prefilled syringes are used to maintain the patency of indwelling catheter Terminated |
NZW | K061497 |
| Jun 13, 2012 | Vygon Corporation Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only
Prefilled syringes are used to maintain the patency of indwelling catheter l Terminated |
NZW | K061497 |
| Jun 13, 2012 | Vygon Corporation Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only
Prefilled syringes are used to maintain the patency of indwelling catheter l Terminated |
NZW | K061497 |
| Jun 13, 2012 | Vygon Corporation Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box
Prefilled syringes are used to maintain the patency of indwelling catheter lumens Terminated |
NZW | K061497 |
| Jun 5, 2012 | Excelsior Medical Corp 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 Terminated |
NZW | K061497 |
| Dec 10, 2010 | Medefil Incorporated Medefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Terminated |
NZW | K092491 |
| Dec 10, 2010 | Medefil Incorporated Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Terminated |
NZW | K092491 |
| Dec 10, 2010 | Medefil Incorporated Medefil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V Terminated |
NZW | K092491 |
| May 9, 2008 | Medefil Incorporated Medefil Heparin I.V. Flush Syringe 1 unit/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. F Terminated |
NZW | None listed |
| May 9, 2008 | Medefil Incorporated Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Terminated |
NZW | None listed |
| May 9, 2008 | Covidien LP Tyco Healthcare Monoject Prefill 100UlmL Heparin
Lock Flush Syringe 5mL, with
BLUNTIP plastic cannula
REF # 8881591125, Tyco Healthcare, Mansfield, MA 02048 Terminated |
NZW | K032438 |
| May 9, 2008 | Covidien LP Tyco Healthcare Monoject Prefill100U/mL Heparin
Lock Flush Syringe 5mL
REF # 8881590125, Tyco Healthcare, Mansfield, MA 02048 Terminated |
NZW | None listed |
| May 9, 2008 | Covidien LP Tyco Healthcare Monoject Prefill 100U/mL Heparin
Lock Flush Syringe 3rnL
REF # 8881590123, Tyco Healthcare, Mansfield, MA 02048 Terminated |
NZW | K032438 |
| May 9, 2008 | Covidien LP Tyco Healthcare Monoject Prefill 100U/mL Heparin
Lock Flush Syringe 10mL
REF # 8881590121, Tyco Healthcare, Mansfield, MA 02048 Terminated |
NZW | K032438 |
| May 9, 2008 | Covidien LP Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula
REF # 8881581125, Tyco Healthcare, Mansfield, MA 02048 Terminated |
NZW | K032438 |
| May 9, 2008 | Covidien LP Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe
2.5mL in 3mL syringe
REF # 8881580300, Tyco Healthcare, Mansfield, MA 02048 Terminated |
NZW | K032438 |
| May 9, 2008 | Covidien LP Tyco Healthcare Tyco HealthcareMonoject Prefill 10U/mL Heparin
Lock Flush Syringe 5mL
REF # 8881580125Tyco Healthcare, Mansfield, MA 02048 Terminated |
NZW | K032438 |
| May 9, 2008 | Covidien LP Tyco HealthcareMonoject Prefill 10U/mL Heparin
Lock Flush Syringe, 3mL
REF # 8881580123, Tyco Healthcare, Mansfield, MA 02048 Terminated |
NZW | K032438 |
| May 9, 2008 | Covidien LP Tyco Healthcare Monoject Prefill 10U/rnL Heparin
Lock Flush Syringe, 10ml, REF # 8881580121, Tyco Healthcare, Mansfield, MA 02048 Terminated |
NZW | None listed |
| May 9, 2008 | Medefil Incorporated Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V Terminated |
NZW | None listed |
| Apr 4, 2008 | Baxter Healthcare Corp. Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial,
25 pack, NDC 0641-0273-25 (NDC 0641-0273-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
NZW | None listed |
| Apr 4, 2008 | Baxter Healthcare Corp. Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 10 units/mL-1 mL vial, 25 pack, NDC 0641-0272-25 (NDC 0641-0272-21: on vial), Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
NZW | None listed |
| Apr 4, 2008 | Baxter Healthcare Corp. Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-30 mL vial, 25 pack, NDC 0641-2443-45, (NDC 0641-2443-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
NZW | None listed |
| Apr 4, 2008 | Baxter Healthcare Corp. Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-10 mL vial, 25 pack, NDC 0641-2436-45, (NDC 0641-2436-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
NZW | None listed |
| Apr 4, 2008 | Baxter Healthcare Corp. Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack , NDC 0641-0389-25, (NDC 0641-0389-21: on vial), Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
NZW | None listed |
| Apr 4, 2008 | Baxter Healthcare Corp. Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-2 mL vial, 25 pack, NDC 0641-0387-25, (NDC 0641-0387-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
NZW | None listed |
| Apr 4, 2008 | Baxter Healthcare Corp. Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 units/mL-30 mL vial; 25 pack, NDC 0641-2442-45 (NDC 0641-2442-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
NZW | None listed |
| Apr 4, 2008 | Baxter Healthcare Corp. Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-10 mL vial; 25 pack, NDC 0641-2438-45, (NDC 0641-2348-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
NZW | None listed |
| Apr 4, 2008 | Baxter Healthcare Corp. Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 u/mL-2 mL vial, 25 pack, NDC-0641-0393-25, (NDC-0641-0393-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
NZW | None listed |
| Apr 4, 2008 | Baxter Healthcare Corp. Baxter HEP LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-1mL vial, 25 Pack, NDC 0641-0392-25 (NDC 0641-0392-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
NZW | None listed |
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