Device product
novaplus, General Purpose Kit, Cat. No. 56603
Z-1947-2021
Product summary
- Event
- Event 87954
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21 cases of 20 units
- Official record key
device-enforcement:Z-1947-2021
Official wording
Reason: There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Code information: Batch Numbers: 0000275724, Exp. 02/15/2022; 0000277619, Exp. 04/15/2022
Distribution pattern: US Nationwide distribution in the states of OH, CO, CA, IL, FL, VA, TX, MN, GA, WA, MA, MD, NY, LA, AZ, OR.
Derived failure modes
-
Unknown
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits