Device 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.
Z-0796-2013
Product summary
- Event
- Event 64084
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80 trays
- Official record key
device-enforcement:Z-0796-2013
Official wording
Reason: Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
Code information: LOT NO. 100212 EXPIRES: 06/2013
Distribution pattern: USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
Derived failure modes
-
Foreign material or chemical contamination
particulate matter