FDA Recall
Terminated
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.
Recall: Z-2720-2016
·
Initiated January 15, 2015
Recall
- Recall Number
- Z-2720-2016
- Event Number
- 75033
- Firm
- Advanced Medical Solutions Ltd. Premier
- FEI Number
- 3003080333
- Product Code
- FRO
- Status
- Terminated
- Root Cause
- Package design/selection
- Initiated
- January 15, 2015
- Posted
- September 2, 2016
- Terminated
- November 23, 2016
- Address
- Park 33 Road, One Windford Industrial Estate Winsford United Kingdom
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
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
Action
Advanced Medical Solutions' (AMS) Sole Customer has already received notification via telephone conference call, followed by emails and correspondence.
Distribution
OH
Quantity
29,204 cartons