Recall Z-2415-2012 ยท KNT Tubes, Gastrointestinal (And Accessories)
Kimberly-Clark Corporation
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.
| Date | Sep 20, 2012 (initiated Jun 22, 2010) |
| Status | Terminated |
| Reason | The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube. |
| Root cause | Nonconforming Material/Component |
| Action | Kimberly-Clark Health Care sent an Urgent Voluntary Medical Device Withdrawal letter dated June 22, 2010, to all affected customers. The letter included a Product Withdrawal Response Sheet which was to be returned to Kimberly-Clark. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and destroy all affected products and complete the attached Product Withdrawal Response Sheet and Fax the form to 920-225-4182. For questions customers should call 770-587-7362. For questions regarding this recall call 770-587-8393. |
| Quantity | 277 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.