AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
Reported: February 12, 2020 Initiated: January 11, 2020 #Z-1011-2020
Product Description
AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
Reason for Recall
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Details
- Recalling Firm
- Cardinal Health
- Units Affected
- 7,659,634 total units
- 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.
- Location
- Waukegan, IL
Frequently Asked Questions
What product was recalled? ▼
AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC. Recalled by Cardinal Health. Units affected: 7,659,634 total units.
Why was this product recalled? ▼
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2020. Severity: Moderate. Recall number: Z-1011-2020.
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