Class II — Kimberly-Clark Corporation
| Recalling firm | KIMBERLY-CLARK CORPORATION |
|---|---|
| Registered facility | KIMBERLY-CLARK PERU S.R.L. - Santa Clara Mill (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled. |
| 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. |
| Quantity | 89,856 (28 units per case) |
| Distribution | Nationwide Distribution |
| Initiated | 2012-07-05 |
| Classified | 2012-11-07 |
| Terminated | 2013-06-13 |
| Recall number | Z-0257-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Kimberly-Clark Corporation (Z-0257-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63598/
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