FDA-Device2012-11-14Class II
ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Kimberly-Clark Corporation
Hazard
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Sold states
Nationwide Distribution
Affected count
89,856 (28 units per case)
Manufactured in
1400 Holcomb Bridge Rd, N/A, Roswell, GA, United States
Products
ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0257-2013Don't want to check this manually?
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