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Recall Observatory FDA recall evidence

Device product

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.

Z-2719-2016

January 15, 2015

Class II

Product summary

Firm
Advanced Medical Solutions Ltd.
Event
Event 75033
Status
Terminated
Classification
Class II
Quantity
47,569 cartons
Official record key
device-enforcement:Z-2719-2016

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: 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

Distribution pattern: OH

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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