FDA Device Intelligence
HomeMEDEFIL, INC. › Medefil Heparin Lock Flush Syringe, 1 Unit/mL

Medefil Heparin Lock Flush Syringe, 1 Unit/mL

MEDEFIL, INC. · Model 2.5mL in 6mL syringe · UDI-DI 30364253444525

NZW Prescription
1
510(k) clearances
803
Adverse events (207 deaths)
44
Recalls
8
Facilities

Description

Medefil Heparin Lock Flush Syringe, 1 Unit/mL, 2.5mL in 6mL Syringe, Does not contain natural rubber latex or preservatives. Contents and its pathway are sterile. Single use.

Recalls

DateFirmReason
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2016-04-28Excelsior Medical CorpCertain 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.
2014-12-19Fresenius Kabi USA, LLCThe lot failed pH specification.
2014-02-19Medefil IncorporatedThe 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
2012-05-11Vygon CorporationManufacturer 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
2012-05-11Vygon CorporationManufacturer 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
2012-05-11Vygon CorporationManufacturer 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
2012-05-11Vygon CorporationManufacturer 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
2012-05-11Vygon CorporationManufacturer 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
2012-05-11Vygon CorporationManufacturer 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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.