Churchill Medical Systems 22Ga Winged Infusion Set 의 리콜

Recall

61653

Class 2

Z-1480-2012

2012-04-16

2012-05-01

Terminated

United States

2013-03-28

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108644

Mislabeled: mbs-2210 code on case label -22ga winged infusion set, ; however, the product label states 20ga mbs-2010 code listed on device label.

The firm, VYGON, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 16, 2012 to its customers via overnight, courier service. The letter described the product, problem and actions to be taken. The customers were instructed to check their stock for the products included within the scope of the recall; count and document their affected inventory; contact Vygon's Customer Service Department at 1-800-473-5414 for return merchandise authorization number; return the affected product; complete and immediately return the Acknowledgement and Inventory Return Form via fax to 215-672-6740 and send the original form with their shipment . Distributors were instructed to communicate this recall to their customers and provide them with the Acknowledgement and Inventory Return Form for completion and return. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@yygonus.com.