Device Recall FMI 105"Oral Surgery Administration Set 의 리콜

Recall

57295

Class 2

Z-1332-2011

2010-11-16

2011-02-16

Terminated

United States

2012-05-01

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95781

Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.

The firm, Churchill Medical/Vygon, sent an "URGENT MEDICAL DEVICE RECALL" letter dated November 16, 2010, via overnight mail to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their stock for affected product; immediately cease use and distribution and quaratine the affected product; contact Vygon's Customer Service Department at 1-800-473-5414 for a return Merchandise Authorization number; complete and return the Recall Acknowledgement and Inventory Return Form via fax to 215-390-2019 and mail return product with form to: Vygon, 103A Park Drive, Montgomeryville, PA 18936, and if the customer is a distributor, they were to provide their customers with a copy of this notification and attached form. Note: An additional follow up communication will be provided to the customers after reconciliation of the returned inventory and all inventory will be credited or replaced. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email at customerservice@vygonus.com.