Recall Z-3016-2020— Cardinal Health 200, LLC

Name: FDA recall Z-3016-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-30

Class II · Terminated

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2020-07-30, terminated 2021-04-28. FDA's recall record names no specific 510(k) clearance for this event. Product: KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.. Reason: Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-07-30
Terminated: 2021-04-28
Firm location: Fort Mill, SC, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.