The Recall Desk

FDA (Drugs) recall action 62775

Custom Medical Specialties, Inc. recalled 3 products on 2012-08-29

The FDA (Drugs) 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
2012-08-29
Critical
0
Units
80

Why these products were recalled

Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags

Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.

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

1–3 of 3

  • SevereFDA (Drugs)··2012-08-29

    Custom Medical Specialties Recalls Sterile Access Trays Due to Sterility Concerns

    Custom Medical Specialties is recalling 35 sterile access trays because they contain sodium chloride bags subject to a separate recall for leaking.

    Product
    Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description.
    Category
    Distribution
    3 states
  • SevereFDA (Drugs)··2012-08-29

    Custom US Breast Core Biopsy Tray Recalled for Sterility Concerns

    Custom Medical Specialties is recalling 25 breast biopsy trays because they contain saline bags subject to a separate recall for leaking.

    Product
    CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine Level, NC 27568, the tray also contains other components not listed in this product…
    Category
    Distribution
    3 states
  • SevereFDA (Drugs)··2012-08-29

    CMS-8934 Custom Phlebectomy Tray Recalled Due to Sterility Assurance Concerns

    Custom Medical Specialties is recalling 20 sterile phlebectomy trays because they contain sodium chloride bags subject to a separate recall for leaking.

    Product
    CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray also contains other components not listed in this product description.
    Category
    Distribution
    3 states