Skip to content
Recall Observatory FDA recall evidence

Device 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

Z-1800-2012

May 11, 2012

Class II

Product summary

Firm
Vygon Corporation
Event
Event 61945
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1800-2012

Official wording

Reason: 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.

Code information: 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.

Distribution pattern: Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.