Z-2720-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2016
- Initiation Date
- January 15, 2015
- Termination Date
- November 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29,204 cartons
Product Description
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.
Reason for Recall
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
Distribution Pattern
OH
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