Device 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.
Z-2425-2012
Product summary
- Event
- Event 62577
- Status
- Terminated
- Classification
- Class III
- Quantity
- 32 cases
- Official record key
device-enforcement:Z-2425-2012
Official wording
Reason: The impacted product was not intended for commercial distribution to end users.
Code information: Product Code: 95221-35, Unit Code: 90372
Distribution pattern: US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.
Derived failure modes
-
Unknown
The impacted product was not intended for commercial distribution to end users.