Device product
Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0018-2015
Product summary
- Event
- Event 69276
- Status
- Terminated
- Classification
- Class I
- Quantity
- 235 cases
- Official record key
device-enforcement:Z-0018-2015
Official wording
Reason: The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Code information: Product Code: C4320-450B Lot Number: 300403
Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.
Derived failure modes
-
Unknown
The affected lots could have NBF concentrations that are lower or higher than the desired specifications.