The Recall Desk

FDA (Devices) recall action 64158

Codman & Shurtleff, Inc. recalled 24 products on 2013-02-27

The FDA (Devices) publishes a recall like this one as 24 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 24 pages.

Products
24
Announced
2013-02-27
Critical
0
Units
5,911

Why these products were recalled

Sterility of device may be compromised due to lack of package integrity

Sterility of device may be compromised due to lack of packaging integrity

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.

1–24 of 24

  • SevereFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling 25 NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling 19 NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility. The recall covers 34 units distributed worldwide.

    Product
    NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Sterility Concerns

    Codman & Shurtleff is recalling NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman & Shurtleff Recalls Neuropath Guiding Catheters Due to Sterility Concerns

    Codman & Shurtleff is recalling 268 units of Neuropath 6Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling 56 NeuroPath 6Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2013-02-27

    Codman & Shurtleff Recalls Neuropath Guiding Catheters Due to Sterility Concerns

    Codman & Shurtleff is recalling Neuropath 6Fx90 Guiding Catheters because package integrity issues may compromise device sterility. The recall covers 10 units distributed worldwide.

    Product
    NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Packaging Integrity Issues

    Codman & Shurtleff is recalling 867 NeuroPath guiding catheters because packaging defects may compromise sterility. The devices were distributed worldwide.

    Product
    NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling 141 units of NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman Neuropath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling Neuropath 6Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2013-02-27

    Codman & Shurtleff Recalls NeuroPath Guiding Catheters Due to Sterility Concerns

    Codman & Shurtleff is recalling 266 units of NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-02-27

    Codman & Shurtleff Recalls NeuroPath Guiding Catheters Due to Sterility Concerns

    Codman & Shurtleff is recalling 1,548 NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Distribution
    0 states