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Heparin Lock Flush Syringe 100 Units/mL

MEDEFIL, INC. · Model 3mL in 12mL syringe · UDI-DI 30364253333331

NZW Prescription

510(k) clearances

800

Adverse events (206 deaths)

Recalls

Facilities

Description

Heparin Lock Flush Syringe 100 Units/mL, 3 mL fill in 12 mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use

Recalls

Date	Firm	Reason
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2016-04-28	Excelsior Medical Corp	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.
2014-12-19	Fresenius Kabi USA, LLC	The lot failed pH specification.
2014-02-19	Medefil Incorporated	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
2012-05-11	Vygon Corporation	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
2012-05-11	Vygon Corporation	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
2012-05-11	Vygon Corporation	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
2012-05-11	Vygon Corporation	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
2012-05-11	Vygon Corporation	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
2012-05-11	Vygon Corporation	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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.