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U.S. Department of Health and Human Services

Class 2 Device Recall Breast Biopsy Kit

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  Class 2 Device Recall Breast Biopsy Kit see related information
Date Initiated by Firm November 26, 2012
Date Posted February 07, 2013
Recall Status1 Terminated 3 on February 08, 2013
Recall Number Z-0797-2013
Recall Event ID 64084
Product Classification Tray, biopsy, without biopsy instruments - Product Code FCH
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.
Code Information LOT NO. 60812 EXPIRES: 11 /2012
Recalling Firm/
Custom Healthcare Systems, Inc.
4205 Eubank Rd
Richmond VA 23231-4328
For Additional Information Contact R. Michael Chou
Manufacturer Reason
for Recall
Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
FDA Determined
Cause 2
Material/Component Contamination
Action Custom Healthcare Systems, Inc. sent an Urgent Recall Letter dated November 19, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check inventory, quarantine affected product and return affected product to Stericycle using the label provided with the letter. Customer were also requested to complete and return the enclosed recall response form. For questions contact Hospira Customer Care at 1-877-946-7747.
Quantity in Commerce 80 trays
Distribution USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.