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

AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC — recall Z-1012-2020

U.S. FDA — Device Enforcement · United States · 2020-01-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1012-2020
Date of alert
2020-01-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cardinal Health
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.
Reported risk: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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.