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Recall

Class II — Kimberly-Clark Corporation

Recalling firmKIMBERLY-CLARK CORPORATION
Registered facilityKIMBERLY-CLARK PERU S.R.L. - Santa Clara Mill (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonThe placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.
ProductKimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.
Quantity766 units
DistributionNationwide Distribution including AL, AK, AZ, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, ME, MA, MI, MN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.
Initiated2010-06-22
Classified2012-09-20
Terminated2013-02-07
Recall numberZ-2416-2012
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 II recall — Kimberly-Clark Corporation (Z-2416-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63001/

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