Recall Z-0938-2012 ยท KNT Tubes, Gastrointestinal (And Accessories)
Kimberly-Clark Corporation
KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE, 22F. Gastro-Enteric Feeding Tube.
| Date | Feb 2, 2012 (initiated Dec 21, 2011) |
| Status | Terminated |
| Reason | The product is misbranded, i.e. the Gastric (center) port may be mislabeled as the Jejunal port, and the Jejunal (side) port mislabeled as the Gastric port. |
| Root cause | Labeling False and Misleading |
| Action | Kimberly-Clark Health Care sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter and e-mail to all affected customers. The communications described the product, problem, and actions to be taken by the customers. Customers were instructed to locate and quarantine any affected product. A Product Recall Response Sheet was enclosed for customers to complete and return to the firm via fax at 920-380-6682. Contact the firm at 770-587-7400 for questions regarding this recall. |
| Quantity | 50 devices |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of CA, CO, ID, IL, MD, MO, NC, NJ, NY, PA, SC, UT, VA, WA, WI, and WV and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K852707 | GASTRO-ENTEROSTOMY TUBE Medical Innovations Corp., Aug 14, 1985 |