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 | Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier. |
| Product | KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider. |
| Quantity | Code 68507 - 6420 cases; Code 68509 - 1281 cases |
| Distribution | Worldwide Distribution -- USA, including the states of AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, Belgium, Hong Kong, Japan, Portugal, and Singapore. |
| Initiated | 2013-03-06 |
| Classified | 2013-03-26 |
| Terminated | 2013-09-16 |
| Recall number | Z-0995-2013 |
| 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-0995-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64689/
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