Device 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.
Z-0797-2013
Product summary
- Event
- Event 64084
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80 trays
- Official record key
device-enforcement:Z-0797-2013
Official wording
Reason: Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
Code information: LOT NO. 60812 EXPIRES: 11 /2012
Distribution pattern: USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
Derived failure modes
-
Foreign material or chemical contamination
particulate matter