FDA-Device2020-06-10Class II
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
Hazard
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Sold states
US Nationwide distribution including in the state of Pennsylvania.
Affected count
2,868 total kits
Manufactured in
Jackson Pointe Commerce, 4050 Jacksons Pointe Ct, Zelienople, PA, United States
Products
Sterile Custom Packs to be used in surgical procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2179-2020Don't want to check this manually?
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