Device Recall DeRoyal Surgical Kits and Vital Signs Anesthesia Circuits 의 리콜

Recall

59854

Class 2

Z-0016-2012

2011-08-23

2011-10-06

Terminated

United States

2013-01-30

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103872

The firm manufactured kits containing a hch device, manufactured by vital signs, that was subsequently recalled because the product may have an occlusion that could prevent proper flow of medical gases or oxygen to the patient.

The firm, DeRoyal, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated September 13, 2011 to its customers. The letter describes product, problem, and actions to be taken. Customers are instructed to identify inventory being recalled and place in quarantine to prevent further use. Constomers were asked to return affected product they have in inventory. DeRoyal will replace this product free of charge. Customers were asked to complete the attached Recall Response Spreadsheet and return as per the instructions. Constomers were asked to return affected product they have in inventory. DeRoyal will replace this product free of charge. Distributors were instructed to perform a sub-recall to their customers. Customers with questions should call 865-362-1037 between 9am and 5pm EST or email recalls@deroyal.com.