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Recall Observatory FDA recall evidence

Device 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

Z-1798-2012

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-1798-2012

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-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.

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.