ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA F...
FDA Recall #Z-2425-2012 — Class III — December 31, 2010
Product Description
ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown 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
The impacted product was not intended for commercial distribution to end users.
Recalling Firm
Kimberly-Clark Corporation — Roswell, GA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
32 cases
Distribution
US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.
Code Information
Product Code: 95221-35, Unit Code: 90372
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated