Recall Z-0257-2013— Kimberly-Clark Corporation
Class II · Terminated
Class II FDA medical device recall by Kimberly-Clark Corporation, initiated 2012-07-05, terminated 2013-06-13. It names 2 FDA 510(k) clearances: K103406, K842115. Product: ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product 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: Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled..
- Recalling firm
- Kimberly-Clark Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-05
- Terminated
- 2013-06-13
- Firm location
- Roswell, GA, United States
510(k) clearances named in this recall
2 on FDA's record- K103406 — MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS
- K842115 — SPUNGARD & SURG. DRAPES-GOWNS & PACKS
K-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
ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product 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
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.