Z-0018-2015 Class I Terminated
FDA device recall Z-0018-2015 was initiated by Richard-Allan Scientific Company on Sep 17, 2014 and is designated Class I. Reason for recall: The affected lots could have NBF concentrations that are lower or higher than the desired specifications. The recall status is terminated (terminated Oct 27, 2016). Affected quantity: 235 cases.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 15, 2014
- Initiation Date
- Sep 17, 2014
- Termination Date
- Oct 27, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 235 cases
Product Description
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.
Reason for Recall
The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
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.
Code Information
Product Code: C4320-450B Lot Number: 300403