FDA Device recall Z-0796-2013
Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case
- FDA Device
- Class II
- terminated
- Published 2013-02-13
On 2013-02-13 the FDA classified a Class II recall of Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case by Custom Healthcare Systems, citing surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0796-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-26 |
| Published | 2013-02-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Custom Healthcare Systems |
| Distribution | US |
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.
Reason
Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
Identifiers
| code_info | LOT NO. 100212 EXPIRES: 06/2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0796-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.