Device Recall GEOMED CABG PACK PGYBK A & B 의 리콜

Recall

79052

Class 2

Z-0637-2018

2018-01-22

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161247

Deroyal manufactured custom sterile surgical kits containing the terumo over pressure safety valve, which were subsequently recalled by terumo cvs due to reports of 'no flow' through the ops valve.

The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" letter dated 01/22/18 to its Consignees on 1/22/18 by overnight mail. The firm sent a follow-up "URGENT! RECALL NOTICE" letter dated 1/29/18. The letters described the product, problem and actions to be taken. The Consignees were instructed to identify affected products; place in quarantine; complete and return the Notice of Return Form, even if they no longer held any affected product, to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com no later than 3/1/18, and return any product they held in stock. If you have further distributed these products, notify your customers of this recall. If you have questions or need assistance with the recall, please contact Regulatory Recall Coordinator and Quality Projects Manager at jmarsh@deroyal.com or by phone 865-362-4203 or email us at recalls@deroyal.com.