FDA Medical Device Recalls (openFDA)
Custom Healthcare Systems, Inc.: 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.
- Recall number
- Z-0797-2013
- Recalling firm
- Custom Healthcare Systems, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2012-11-26
- Posted
- 2013-02-07
- Terminated
- 2013-02-08
- 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.
- Lot, serial or model codes
- LOT NO. 60812 EXPIRES: 11 /2012
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FCH
- Firm FEI
- 1121091
- Firm city
- Richmond
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28