PlainRecalls
FDA Devices Moderate Class II Terminated

AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511

Reported: February 12, 2020 Initiated: January 11, 2020 #Z-1034-2020

Product Description

AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511

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 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511. 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-1034-2020.