Heparin, Vascular Access Flush
General Hospital · 21 CFR 880.5200
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Recent MDR events
800 adverse event reports on file
- HEPARIN FLUSH 100UNITS/ML 5ML LOCKJul 1, 2026InjuryBecton Dickinson And CompanyMW5190163
- BD SYRINGE 5ML HEPARIN 10 UNITNov 20, 2025MalfunctionBd Medical (bd West) Medical Surgical1911916-2025-00753
- BD SYRINGE 5ML HEPARIN 10 UNITSep 22, 2025MalfunctionBd Medical (bd West) Medical Surgical1911916-2025-00650
- SYRINGE 5ML HEPARIN 10 UNITMay 9, 2025MalfunctionBecton Dickinson1911916-2025-00335
- SYRINGE 5ML HEPARIN 10 UNITMay 6, 2025MalfunctionBecton Dickinson1911916-2025-00330
- SYRINGE 5ML HEPARIN 10 UNITMay 5, 2025MalfunctionBecton Dickinson1911916-2025-00325
- SYRINGE 5ML HEPARIN 10 UNITMay 2, 2025MalfunctionBecton Dickinson1911916-2025-00320
- SYRINGE 5ML HEPARIN 10 UNITApr 29, 2025MalfunctionBecton Dickinson1911916-2025-00315
- SYRINGE 5ML HEPARIN 10 UNITApr 3, 2025MalfunctionBecton Dickinson1911916-2025-00262
- SYRINGE 5ML HEPARIN 10 UNITApr 2, 2025MalfunctionBecton Dickinson1911916-2025-00258
Event type breakdown
Recalls
44 recall events for this product code
- Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedAug 26, 2022
Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL Fill in 10 mL Syringe
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1596-2022 · View FDA record ↗ - Excelsior Medical CorpTerminatedJun 14, 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.
Z-1989-2016 · View FDA record ↗ - Fresenius Kabi USA, LLCTerminatedJan 29, 2015
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-
The lot failed pH specification.
Z-1032-2015 · View FDA record ↗ - Medefil IncorporatedTerminatedMar 6, 2014
Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
The bar code that is printed on the Master Carton label does not correspond to the product code fully displayed on the Master Carton label. The non-matching information can only be detected by using a bar code reader. The defective bar codes will be read as Product No. MIH-3335 ( Heparin I.V. Flush Syringe 100 units/mL; 5 mL fill in 12 mL Syringe) whereas this product is actually Product No. MIH-3333 (Heparin I.V. Flush Syringe 100 units/mL; 3 mL fill in 12 mL Syringe).
Z-1149-2014 · View FDA record ↗ - App Pharmaceuticals LlcTerminatedJun 19, 2012
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
CGMP Deviations: Incomplete documentation associated with test results.
Z-1824-2012 · View FDA record ↗ - App Pharmaceuticals LlcTerminatedJun 19, 2012
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 L
CGMP Deviations: Incomplete documentation associated with test results.
Z-1825-2012 · View FDA record ↗ - Vygon CorporationTerminatedJun 13, 2012
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box
Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Z-1797-2012 · View FDA record ↗ - Vygon CorporationTerminatedJun 13, 2012
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only
Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Z-1798-2012 · View FDA record ↗ - Vygon CorporationTerminatedJun 13, 2012
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only
Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Z-1799-2012 · View FDA record ↗ - Vygon CorporationTerminatedJun 13, 2012
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only
Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
Z-1800-2012 · View FDA record ↗
Registered firms
12 firms currently registered for this product code
Excelsior Medical Llc
NEPTUNE, NJ, US
Excelsior Medical Llc
Freehold, NJ, US
Becton Dickinson And Company
COLUMBUS, NE, US
Dylan Lucas International Inc
Vaughan Ontario, CA
Medefil, Inc.
GLENDALE HEIGHTS, IL, US
Becton Dickinson
FRANKLIN LAKES, NJ, US
Carefusion 2200, Inc.
Vernon Hills, IL, US
Mainline Medical Dental Supply
North York Ontario, CA
510(k) clearances
7 clearances for this product code
- Becton, Dickinson and CompanyFeb 27, 2017
K163591 · BD PosiFlush Heparin Lock Flush Syringe
- Excelsior Medical CorporationNov 14, 2014
K133446 · HEPARIN LOCK / FLUSH SYRINGES
- App Pharmaceuticals, LLCJun 18, 2010
K092938 · HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710
- Medefil, Inc.Feb 3, 2010
K092491 · MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES
- Becton, Dickinson & COJun 10, 2009
K090680 · HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE
- Excelsior Medical Corp.Feb 23, 2007
K061497 · SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
- Excelsior Medical Corp.May 13, 2003
K023740 · SYREX PRE-FILLED SYRINGE