Z-1800-2012Class II

Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per...

Name: Z-1800-2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per...
Creator: Vygon Corporation
Published: 2012-05-11
License: https://open.fda.gov/license/

Vygon U.S.A. / initiated 2012-05-11 / Terminated / root cause: manufacturing process

FDA source

Vygon Corporation began a recall of 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... on 2012-05-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1800-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-11
Posted: 2012-06-13
Terminated: 2013-03-11
Recalling firm: Vygon U.S.A.
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: NZW Heparin, Vascular Access Flush
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: VYCON sent an URGENT MEDICAL DEVICE RECALL letter dated May 10, 2012, to all affected customers. The firm expanded their recall on May 25, 2012 by sending a second letter with additional lots and products. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory and quarantine any affected product. Customers should contact Vycon's Customer Service Department at 1-800-473-5414 for a Return Merchandise Authorization number. Customers were instructed to enter the number on the space provided on the Recall Acknowledgment and Inventory Return Form, sign and date form and fax to Vycon at 215-672-6740. Customers should return the affected product as well as the original signed Recall Acknowledgment and Inventory Form using the instructions from Customer Service involving product pick-up. All inventory will be credited. If product was further distributed the Urgent Medical Device Recall letter should be provided to their customers. For questions regarding this recall call 215-672-6740.
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1800-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1797-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-13
Z-1798-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-13
Z-1799-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-13
Z-1800-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-13
Z-1801-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-13
Z-1802-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-13
Z-1803-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-13
Z-1804-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-13
Z-1805-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-13
Z-1806-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-13
Z-1807-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-13
Z-1808-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-13

Product code NZW

K061497Class IISyrex Heparin Lock Flush Syringe, 1 Unit/ml & 2 Units/mlExcelsior Medical Corp. / cleared 2007-02-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)