Recall Z-1799-2012 ยท NZW Heparin, Vascular Access Flush
Vygon Corporation
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
| Date | Jun 13, 2012 (initiated May 11, 2012) |
| Status | Terminated |
| 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. |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061497 | SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML Excelsior Medical Corp., Feb 23, 2007 |