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.
FDA Recall Z-0797-2013 · Posted 2013-02-07
Recalling FirmCustom Healthcare Systems, Inc.
Recall StatusTerminated
Product CodeFCH
Date Initiated2012-11-26
Date Terminated2013-02-08
Product Quantity80 trays
Reason for Recall
Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
Firm 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.
Root Cause
Material/Component Contamination
Distribution Pattern
USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.