FDA recall Z-0400-2022

Product

Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

Reason for recall

This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.

Distribution

NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH

Key facts

Status

Terminated

Initiation date

2021-10-28

Report date

2021-12-29

Termination date

2023-08-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Peachtree Corners, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0400-2022