Recall Z-2017-2012— Kimberly-Clark Corporation
Class II · Terminated
Class II FDA medical device recall by Kimberly-Clark Corporation, initiated 2009-09-17, terminated 2012-07-19. It names one FDA 510(k) clearance: K091357. Product: MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.. Reason: Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns..
- Recalling firm
- Kimberly-Clark Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2009-09-17
- Terminated
- 2012-07-19
- Firm location
- Roswell, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.
Reason for recall
Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.
Data sourced from openFDA. This site is unofficial and independent of the FDA.