Product Wiki · Recalls · U.S. FDA — Device Enforcement

KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus. — recall Z-3016-2020

U.S. FDA — Device Enforcement · United States · 2020-07-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3016-2020
Date of alert
2020-07-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cardinal Health 200, LLC
Product category
device
Product type
Devices
Reported risk: Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.