The Recall Desk

FDA (Devices) recall action 75033

Advanced Medical Solutions Ltd. recalled 2 products on 2016-09-14

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-09-14
Critical
0
Units
76,773

Why these products were recalled

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

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • LowFDA (Devices)··2016-09-14

    ReliaMed Silver Alginate Dressing Recalled for Missing Instructions

    Advanced Medical Solutions is recalling ReliaMed Silver Alginate dressings because some cartons are missing the required Instructions For Use leaflet.

    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.
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-09-14

    ReliaMed Alginate Dressings Recalled for Misplaced Instructions

    Advanced Medical Solutions is recalling ReliaMed Alginate/CMC dressings because instructions for use were misplaced in the packaging.

    Product
    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.
    Category
    Distribution
    1 state