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
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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/ Manufacturer |
Custom Healthcare Systems, Inc. 4205 Eubank Rd Richmond VA 23231-4328
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For Additional Information Contact | R. Michael Chou 804-421-5959 |
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 |
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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.
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