The Recall Desk

FDA (Devices) recall action 88808

Cook Inc. recalled 2 products on 2021-11-24

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
2021-11-24
Critical
0
Units
4,789

Why these products were recalled

Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.

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)··2021-11-24

    Transseptal Needle with Catheter Recalled Due to Rust Contamination Risk

    Cook Inc. is recalling transseptal needles that may contain rust on internal or external surfaces. If used, the rust could cause increased procedural time or inflammatory reactions, potentially leading to systemic complications.

    Product
    Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-11-24

    Transseptal Needles Recalled Due to Rust Contamination Risk

    Cook Inc. is recalling transseptal needles that may contain undetected rust, which could cause inflammatory reactions, systemic responses, and potentially permanent impairment.

    Product
    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
    Category
    Distribution
    0 states