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Recall

Class III — Kimberly-Clark Corporation

Recalling firmKIMBERLY-CLARK CORPORATION
Registered facilityKIMBERLY-CLARK PERU S.R.L. - Santa Clara Mill (the firm's only registered facility)
ClassificationClass III
StatusTerminated
ReasonThe impacted product was not intended for commercial distribution to end users.
ProductULTRA 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.
Quantity32 cases
DistributionUS (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.
Initiated2010-12-31
Classified2012-09-20
Terminated2012-11-01
Recall numberZ-2425-2012
InitiationVoluntary: 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 III recall — Kimberly-Clark Corporation (Z-2425-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62577/

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