RecallRadar

FDA Device recall Z-2719-2016

ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packagin…

On 2016-09-14 the FDA classified a Class II recall of ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packagin… by Advanced Medical Solutions, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2719-2016
ClassificationClass II
Statusterminated
Initiated2015-01-15
Published2016-09-14
Last updated2026-09-13 11:54 UTC
CompanyAdvanced Medical Solutions
DistributionOH

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.

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

Identifiers

code_info
AMS Lot number 51594 51800 51883 51928 52023 52024 52002 52065 52230 52750 52754 52782 52775 52811 53213…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2719-2016%22

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