Recall Z-0796-2013 ยท FCH Tray, Biopsy, Without Biopsy Instruments
Custom Healthcare Systems, Inc.
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.
| Date | Feb 7, 2013 (initiated Nov 26, 2012) |
| Status | Terminated |
| Reason | Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter. |
| Root cause | 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 | 80 trays |
| Distribution | USA Nationwide Distribution including the states GA, OH, GA, NC and ME. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.