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 Flush Syringes and kits containing the syringes.

Agency Publication Date: June 13, 2012

Affected Products

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

Product Code VIH-4423 -- lots 92-057-9D, 95-041-9D, 97-063-9D, and 92-155-9D.

Lot Numbers:

VIH-4423

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

Product Code VIH-2233 -- lots 87-133-9D, 93-088-9D, 97-066-9D, 00-015-9D, 03-012-9D, 03-113-9D, 03-116-9D, 08-067-9D, 08-071-9D, 95-027-9D, 95-029-9D, and 08-073-9D.

Lot Numbers:

VIH-2233

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

Product Code VIH-2235 -- lots 86-088-9D, 87-106-9D, 89-080-9D, 90-048-9D, 91-058-9D, 91-059-9D, 91-135-9D, 92-110-9D, 93-062-9D, 93-063-9D, 94-034-9D, 94-044-9D, 95-030-9D, 95-052-9D, 97-051-9D, 97-053-9D, 97-071-9D, and 97-083-9D.

Lot Numbers:

VIH-2235

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

Product Code VIH-3333 -- lots 91-036-9D, 92-079-9D, 97-040-9D, 99-130-9D, 01-005-9D, 01-062-9D, 01-063-9D, 03-082-9D, 07-046-9D, 08-060-9D, 95-070-9D, 96-006-9D, 94-010-9D, 97-040-9D, and 10-010-9D.

Lot Numbers:

VIH-3333

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

Product Code VIH-3335 -- lots 89-099-9D, 89-143-9D, 90-093-9D, 92-073-9D, 92-097-9D, 92-124-9D, 92-140-9D, 92-142-9D, 94-009-9D, 94-013-9D, 94-045-9D, 94-140-9D, 94-147-9D, 95-013-9D, 95-014-9D, 95-109-9D, 96-049-9D, 98-010-9D, 99-041-9D, 00-012-9D, 01-036-9D, 01-055-9D, 02-065-9D, 02-067-9D, 02-100-9D, 07-020-9D, 07-031-9D, 07-033-9D, 07-041-9D, 08-037-9D, 08-048-9D, 09-007-9D, 09-009-9D, 09-022-9D, 10-001-9D, 10-012-9D, 10-049-9D, 10-039-9D, 12-022-9D, and 12-026-9D.

Lot Numbers:

VIH-3335

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

Product Code AMS-9848CP-11 -- lots 10J80 and 10K62.

Lot Numbers:

AMS-9848CP-11

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

Product Code AMS-9889CP-7 -- lot 10I86.

Lot Numbers:

AMS-9889CP-7

10I86

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

Product Code AMS-8280CP-4 -- lots 10K16, 10L20, 11A78, 11B24, 11B16, 11C70, and 11D14.

Lot Numbers:

AMS-8280CP-4

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

Product Code AMS-8522CP-3 - lot 10K50.

Lot Numbers:

AMS-8522CP-3

10K50

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

Product Code AMS-9437CP -- lots 1112059, 1112106, 1202101, 1101505, 1101026, 1103020, 1104130, 1103190, and 1109064.

Lot Numbers:

AMS-9437CP

Product: Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

Product Code AMS-7091CP - lot 11C119.

Lot Numbers:

AMS-7091CP

11C119

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

Product Code AMS-8172CP-5 -- lots 10J15, 10K09, 10K19, 11A77, 11C103, 11D79, 11F66, 11H18, 11J41, and 11L54.

Lot Numbers:

AMS-8172CP-5

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 61945

Status: Resolved

Manufacturer: Vygon Corporation

Manufactured In: United States

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product Code VIH-4423 -- lots 92-057-9D, 95-041-9D, 97-063-9D, and 92-155-9D.

Lot Numbers:

VIH-4423

Product Code VIH-2233 -- lots 87-133-9D, 93-088-9D, 97-066-9D, 00-015-9D, 03-012-9D, 03-113-9D, 03-116-9D, 08-067-9D, 08-071-9D, 95-027-9D, 95-029-9D, and 08-073-9D.

Lot Numbers:

VIH-2233

Lot Numbers:

VIH-2235

Product Code VIH-3333 -- lots 91-036-9D, 92-079-9D, 97-040-9D, 99-130-9D, 01-005-9D, 01-062-9D, 01-063-9D, 03-082-9D, 07-046-9D, 08-060-9D, 95-070-9D, 96-006-9D, 94-010-9D, 97-040-9D, and 10-010-9D.

Lot Numbers:

VIH-3333

Lot Numbers:

VIH-3335

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

Product Code AMS-9848CP-11 -- lots 10J80 and 10K62.

Lot Numbers:

AMS-9848CP-11

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

Product Code AMS-9889CP-7 -- lot 10I86.

Lot Numbers:

AMS-9889CP-7

10I86

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

Product Code AMS-8280CP-4 -- lots 10K16, 10L20, 11A78, 11B24, 11B16, 11C70, and 11D14.

Lot Numbers:

AMS-8280CP-4

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

Product Code AMS-8522CP-3 - lot 10K50.

Lot Numbers:

AMS-8522CP-3

10K50

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

Product Code AMS-9437CP -- lots 1112059, 1112106, 1202101, 1101505, 1101026, 1103020, 1104130, 1103190, and 1109064.

Lot Numbers:

AMS-9437CP

Product: Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

Product Code AMS-7091CP - lot 11C119.

Lot Numbers:

AMS-7091CP

11C119

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

Product Code AMS-8172CP-5 -- lots 10J15, 10K09, 10K19, 11A77, 11C103, 11D79, 11F66, 11H18, 11J41, and 11L54.

Lot Numbers:

AMS-8172CP-5