The Recall Desk

FDA (Devices) recall action 75637

Teleflex Medical recalled 5 products on 2016-12-07

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2016-12-07
Critical
0
Units
113,647

Why these products were recalled

Sterility: Due to a potential incomplete seal on the outer sterile package.

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.

1–5 of 5

  • HighFDA (Devices)··2016-12-07

    Teleflex Recalls Arrow OnControl Aspiration System Trays Due to Sterility Concerns

    Teleflex Medical is recalling specific lots of Arrow OnControl Ported Aspiration System Trays because the outer sterile package may have an incomplete seal.

    Product
    ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-12-07

    Teleflex Recalls Arrow OnControl Bone Marrow Biopsy System Trays

    Teleflex Medical is recalling 113,647 units of Arrow OnControl Bone Marrow Biopsy System Trays due to a potential incomplete seal on the outer sterile package.

    Product
    ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow B
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-12-07

    Teleflex Recalls Arrow OnControl Bone Lesion Biopsy System Trays

    Teleflex Medical is recalling Arrow OnControl Bone Lesion Biopsy System trays due to a potential incomplete seal on the outer sterile package.

    Product
    ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-12-07

    Teleflex Recalls OnControl Biopsy System Ported Needle Trays for Sterility Concerns

    Teleflex Medical is recalling OnControl Biopsy System Ported Needle Trays due to a potential incomplete seal on the outer sterile package.

    Product
    OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow cor
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-12-07

    Teleflex Recalls Arrow OnControl Bone Marrow Biopsy Systems for Sterility Concerns

    Teleflex Medical is recalling Arrow OnControl Bone Marrow Biopsy Systems due to a potential incomplete seal on the outer sterile package.

    Product
    ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone
    Category
    Distribution
    0 states