Device Recall Lifeguard Infusion Set with Smartsite, 20Ga, 1 의 리콜

Recall

64464

Class 2

Z-0914-2013

2013-01-21

2013-03-06

Terminated

United States

2013-09-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116188

The label on the device states that the item number is clgy-2210 when the item number on the device label should read clgy-2010. this is a 20ga huber needle set; however, the product label states the pouch contains a 22ga set.

Vycon sent an Urgent Medical Device Recall letter dated January 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed check their stock for the affected product and immediately cease use and distribution and quarantine all affected product immediately. Count and document their affected inventory on the Recall Acknowledgement and Inventory Return Form. Customers were instructed to fax or email the form to Vygon including customer contact information. All affected product would be credited or replaced at no cost to the customer. Customers with questions were instructed to call 1-800-473-5414, or by e-mail at customerservice@vygonus.com. For questions regarding this recall call 603-743-5988.