Device product
ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
Z-2720-2016
Product summary
- Event
- Event 75033
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29,204 cartons
- Official record key
device-enforcement:Z-2720-2016
Official wording
Reason: 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
Code information: 51593 51772 52013 52001 52074 52668 52752 52756 52810 52851 53233 53234 53467 53655 53727 53685 53769 01129 01332 01569 02390 02584 02429 03696 03813 04095 04137
Distribution pattern: OH
Derived failure modes
-
Unknown
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