The Recall Desk

FDA (Devices) recall action 72997

Rymed Technologies, LLC recalled 2 products on 2016-01-27

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
2016-01-27
Critical
0
Units
543,000

Why these products were recalled

Potential for the female luer component of the InVision-Plus IV connector to crack during use.

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.

1–2 of 2

  • HighFDA (Devices)··2016-01-27

    Rymed InVision-Plus IV Connectors Recalled for Cracking Risk

    Rymed Technologies is recalling InVision-Plus IV connectors because the female luer component may crack during use.

    Product
    InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-01-27

    Rymed InVision-Plus IV Connector Recall Due to Cracking Risk

    Rymed Technologies is recalling 46,600 InVision-Plus CS Needleless IV Connectors because the female luer component may crack during use.

    Product
    InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during
    Category
    Distribution
    0 states