FDA recall Z-1947-2021

Medical Action Industries, Inc. 306 · Class II · device

Product

novaplus, General Purpose Kit, Cat. No. 56603

Reason for recall

There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits

Distribution

US Nationwide distribution in the states of OH, CO, CA, IL, FL, VA, TX, MN, GA, WA, MA, MD, NY, LA, AZ, OR.

Key facts

Status
Terminated
Initiation date
2021-05-11
Report date
2021-06-30
Termination date
2023-05-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Arden, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1947-2021