Recall Z-2425-2012— Kimberly-Clark Corporation
Class III · Terminated
Class III FDA medical device recall by Kimberly-Clark Corporation, initiated 2010-12-31, terminated 2012-11-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: The impacted product was not intended for commercial distribution to end users..
- Recalling firm
- Kimberly-Clark Corporation
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2010-12-31
- Terminated
- 2012-11-01
- Firm location
- Roswell, GA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.