Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Us

FDA device recall Z-0797-2013 · posted 2013-02-07 · Terminated

Recall details

Recalling firm

Custom Healthcare Systems, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

FCH

Quantity affected

80 trays

Distribution

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

Date initiated

2012-11-26

Date posted

2013-02-07

Date terminated

2013-02-08

Location

Richmond, VA