Z-2425-2012 Class III Terminated
FDA device recall Z-2425-2012 was initiated by Kimberly-Clark Corporation on December 31, 2010 and is designated Class III. Reason for recall: The impacted product was not intended for commercial distribution to end users. The recall status is terminated (terminated November 1, 2012). Affected quantity: 32 cases.
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2012
- Initiation Date
- December 31, 2010
- Termination Date
- November 1, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 cases
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.
Distribution Pattern
US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.
Code Information
Product Code: 95221-35, Unit Code: 90372