Custom Healthcare Systems, Inc. recalls Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile

Recalled February 13, 2013 · FDA recall Z-0796-2013 · Custom Healthcare Systems

Hazard

Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter. · FDA Class II

Units

80 trays

Sold at

USA Nationwide Distribution including the states GA, OH, GA, NC and ME.

Description

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

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.

Manufacturer(s)

Custom Healthcare Systems, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →