FDA (Devices) recall action 61945

Vygon Corporation recalled 12 products on 2012-06-20

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products: 12
Announced: 2012-06-20
Critical: 0
Units: —

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–12 of 12

ModerateFDA (Devices)··2012-06-20
Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action
Vygon Corporation is voluntarily recalling specific lots of VY Flush Heparin Lock Flush Syringes and related kits. The recall covers nationwide distribution across 23 states.
Product
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
Category
Distribution
23 states
ModerateFDA (Devices)··2012-06-20
Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action
Vygon Corporation is voluntarily recalling specific lots of VY Flush Heparin Lock Flush Syringes. The recall covers syringes and kits distributed nationwide.
Product
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 lumens
Category
Distribution
23 states
ModerateFDA (Devices)··2012-06-20
Vygon Recalls Heparin Lock Flush Syringes and PICC Insertion Kits
Vygon is recalling heparin lock flush syringes and kits containing them due to a voluntary recall of VY Flush Heparin Lock Flush Syringes.
Product
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
Category
Distribution
23 states
ModerateFDA (Devices)··2012-06-20
Vygon Recalls Heparin Lock Flush Syringes and Dressing Change Kits
Vygon Corporation is voluntarily recalling Heparin Lock Flush Syringes and kits containing them due to a related recall of VY Flush Heparin Lock Flush Syringes.
Product
Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Category
Distribution
23 states
ModerateFDA (Devices)··2012-06-20
Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action
Vygon Corporation is voluntarily recalling multiple lots of VY Flush Heparin Lock Flush Syringes and related kits. The recall covers products distributed nationwide.
Product
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 lumens
Category
Distribution
23 states
ModerateFDA (Devices)··2012-06-20
Vygon Recalls Heparin Lock Flush Syringes and Kits
Vygon Corporation is voluntarily recalling Heparin Lock Flush Syringes and kits containing them due to a related recall of VY Flush Heparin Lock Flush Syringes.
Product
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
Category
Distribution
23 states
ModerateFDA (Devices)··2012-06-20
Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action
Vygon Corporation is voluntarily recalling multiple lots of VY Flush Heparin Lock Flush Syringes and related kits. The syringes are used to maintain the patency of indwelling catheter lumens.
Product
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 lumens
Category
Distribution
23 states
ModerateFDA (Devices)··2012-06-20
Vygon Recalls Heparin Lock Flush Syringes and Kits
Vygon is voluntarily recalling Heparin Lock Flush Syringes and kits containing them due to a related recall of VY Flush Heparin Lock Flush Syringes.
Product
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Category
Distribution
23 states
ModerateFDA (Devices)··2012-06-20
Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action
Vygon Corporation is voluntarily recalling multiple lots of VY Flush Heparin Lock Flush Syringes and related kits nationwide.
Product
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 lumens
Category
Distribution
23 states
ModerateFDA (Devices)··2012-06-20
Vygon Recalls Heparin Lock Flush Syringes and Kits
Vygon Corporation is recalling Heparin Lock Flush Syringes and kits due to a voluntary recall of related VY Flush Heparin Lock Flush Syringes.
Product
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Category
Distribution
23 states
ModerateFDA (Devices)··2012-06-20
Vygon Recalls Heparin Lock Flush Syringes and PICC Insertion Kits
Vygon is recalling Heparin Lock Flush Syringes and kits containing them due to a voluntary recall of similar syringes by the manufacturer.
Product
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
Category
Distribution
23 states
ModerateFDA (Devices)··2012-06-20
Vygon Recalls Heparin Lock Flush Syringes and Kits
Vygon is recalling heparin lock flush syringes and kits due to a manufacturer recall of VY Flush Heparin Lock Flush Syringes.
Product
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
Category
Distribution
23 states