FDAFDA · Food and drugs·Recall number Z-2415-2012
Kimberly-Clark MIC Safety 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.
Published September 26, 2012 · Recall initiated: June 22, 2010
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Kimberly-Clark Corporation
- Distributor
- Nationwide 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.
- Lot
- Lots AW916102A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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