Device Recall Straight Ventricular Catheter 의 리콜

Recall

75065

Class 2

Z-2905-2016

2016-08-23

Terminated

United States

2017-03-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149270

During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

Integra sent an "Urgent Voluntary Medical Device Recall" Letter and Recall Acknowledgement and Return Form dated August 23, 2016 to their affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was advised if they have distributed the product to identify those customers and forward a copy of the enclosed Integra Medical Device Voluntary Recall Notification to those customers. The customer was also asked to review their inventory for the affected product and complete the attached form indicating whether or not they have any of the affected product in their inventory. Customers with questions were instructed to contact Customer Service at 1-800-654-2873.