PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: November 14, 2012 Initiated: July 5, 2012 #Z-0257-2013

Product Description

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.

Reason for Recall

Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.

Details

Units Affected
89,856 (28 units per case)
Distribution
Nationwide Distribution
Location
Roswell, GA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Kimberly-Clark Corporation. Units affected: 89,856 (28 units per case).
Why was this product recalled?
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 14, 2012. Severity: Moderate. Recall number: Z-0257-2013.