FDA recall Z-3016-2020

Cardinal Health 200, LLC · Class II · device

Product

KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.

Reason for recall

Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.

Distribution

US Nationwide distribution including the state of North Carolina.

Key facts

Status
Terminated
Initiation date
2020-07-30
Report date
2020-10-07
Termination date
2021-04-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fort Mill, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3016-2020