Recall Z-1806-2012— Vygon Corporation

Name: FDA recall Z-1806-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-11

Class II · Terminated

Class II FDA medical device recall by Vygon Corporation, initiated 2012-05-11, terminated 2013-03-11. It names one FDA 510(k) clearance: K061497. 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. 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..

Recalling firm: Vygon Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-05-11
Terminated: 2013-03-11
Firm location: Montgomeryville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K061497 — SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/MLExcelsior Medical Corp.·cleared 2007-02-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.