KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE, 22F. Gastro-Enteric Feeding Tube.
FDA device recall Z-0938-2012 · posted 2012-02-02 · Terminated
Recall details
- Recalling firm
- Kimberly-Clark Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 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.
- Date initiated
- 2011-12-21
- Date posted
- 2012-02-02
- Date terminated
- 2012-07-02
- Location
- Roswell, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GASTRO-ENTEROSTOMY TUBE (K852707) | Medical Innovations Corp. | 1985-08-14 |