The Recall Desk

FDA (Devices) recall action 81460

Numed Inc recalled 2 products on 2018-12-05

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
2018-12-05
Critical
0
Units
200

Why these products were recalled

Instructions for Use booklets were not included on the outer pouch

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

  • ModerateFDA (Devices)··2018-12-05

    Numed Multi-Track Angiographic Catheter Recall for Missing Instructions

    Numed Inc is recalling 100 units of Multi-Track Angiographic Catheters because the Instructions for Use booklets were not included on the outer pouch.

    Product
    Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel
    Category
    Distribution
    1 state
  • LowFDA (Devices)··2018-12-05

    Numed Multi-Track Angiographic Catheter Recall for Missing Instructions

    Numed Inc is recalling 100 units of Multi-Track Angiographic Catheters because Instructions for Use booklets were not included on the outer pouch.

    Product
    Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel
    Category
    Distribution
    1 state