Recall Z-1803-2012— Vygon Corporation

Name: FDA recall Z-1803-2012
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. PORT-A-CATH 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. PORT-A-CATH 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.