Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Advanced Medical Solutions
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Class I - Dangerous
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse
On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse