The Recall Desk

FDA (Devices) recall action 64084

Custom Healthcare Systems, Inc. recalled 2 products on 2013-02-13

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
2013-02-13
Critical
0
Units
160

Why these products were recalled

Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.

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.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2013-02-13

    Custom Breast Biopsy Tray Recalled for Potential Particulate Matter

    Custom Healthcare Systems is recalling 80 breast biopsy trays because they may contain particulate matter in the pharmaceuticals used for injection.

    Product
    Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2013-02-13

    Custom Breast Biopsy Tray Recalled for Potential Particulate Matter

    Custom Healthcare Systems is recalling breast biopsy trays because they may contain particulate matter in the included sodium chloride.

    Product
    Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
    Category
    Distribution
    4 states