Z-2415-2012 Class II Terminated
FDA device recall Z-2415-2012 was initiated by Kimberly-Clark Corporation on June 22, 2010 and is designated Class II. Reason for recall: The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube. The recall status is terminated (terminated February 7, 2013). Affected quantity: 277 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2012
- Initiation Date
- June 22, 2010
- Termination Date
- February 7, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 277 units
Product Description
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.
Reason for Recall
The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.
Distribution Pattern
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.
Code Information
Lots AW916102A