Custom Healthcare Systems, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0796-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 26, 2012

Date Posted: February 13, 2013

Recall Number: Z-0796-2013

Event ID: 64084

Reason for Recall:

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

Status: Terminated

Product Quantity: 80 trays

Code Information:

LOT NO. 100212 EXPIRES: 06/2013

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated