The Recall Desk

FDA (Devices) recall action 82659

Integra LifeSciences Corp. recalled 3 products on 2019-05-29

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2019-05-29
Critical
0
Units
126,306

Why these products were recalled

The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.

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.

1–3 of 3

  • HighFDA (Devices)··2019-05-29

    Integra MoniTorr CSF Drainage System Recalled for Stopcock Breakage

    Integra LifeSciences is recalling MoniTorr CSF Drainage Systems due to a complaint trend regarding stopcock breakage.

    Product
    MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the lumb
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-05-29

    Integra LifeSciences Recalls LimiTorr and MoniTorr Stopcock Components

    Integra LifeSciences is recalling LimiTorr and MoniTorr stopcock components due to a complaint trend regarding breakage.

    Product
    LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML LimiTorr INS9030SP1 INS-9030SP1 LIMITORR VOLUME LIMITING EVD 30 ML Product Usage: The LimiTorr
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-05-29

    Integra LifeSciences Recalls MoniTorr CSF Drainage Systems Due to Stopcock Breakage

    Integra LifeSciences is recalling MoniTorr CSF Drainage Systems because the LimiTorr Transducer Mount and MoniTorr Panel Mount stopcocks may break.

    Product
    MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System w/Patient Line One Way Valve w MoniTorr 10110 10-110 CSF Drainage System used with Pole Mount System MoniTorr 10140 10-140 CSF Drainage System w/Vinyl Measuring Str
    Category
    Distribution
    0 states