Rappel de Device Recall Churchill Medical Systems, Inc. PORTACATH Tray Kit

Recall

61945

Class 2

Z-1803-2012

2012-05-11

2012-06-13

Terminated

United States

2013-03-11

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109558

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.

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.