Z-2719-2016 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
- 47,569 cartons
Product Description
ReliaMed¿ Silver 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
AMS Lot number 51594 51800 51883 51928 52023 52024 52002 52065 52230 52750 52754 52782 52775 52811 53213 53488 53532 53628 53665 53633 53981 53989 54066 01334 01263 01341 02112 02438 02583 02592 02582 02523 03138 03667 03675 03819 03908 03779 04254 04142 05996 06086 06256