Recall Z-0796-2013
Custom Healthcare Systems, Inc. · initiated November 26, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: LOT NO. 100212 EXPIRES: 06/2013
Reason for recall
Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
FDA-determined cause: Material/Component Contamination
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.
Details
- Recall number
- Z-0796-2013
- Initiated
- November 26, 2012
- Posted by FDA
- February 7, 2013
- Terminated
- February 8, 2013
- Product code
- FCH – Tray, Biopsy, Without Biopsy Instruments
- Quantity
- 80 trays
- Distribution
- USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
- Recalling firm
- Custom Healthcare Systems, Inc., Richmond, VA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0797-2013 Class II | Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1…Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter. | 11/26/2012Terminated |