KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE, 22F. Gastro-Enteric Feeding Tube.
This recall has been terminated (originally issued February 2, 2012).
- Company
- Kimberly-Clark Corporation
- Recall Initiated
- December 21, 2011
- Posted
- February 2, 2012
- Terminated
- July 2, 2012
- Recall Number
- Z-0938-2012
- Quantity
- 50 devices
- Firm Location
- Roswell, GA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Catalogue number: 0210-22, Lot number: AA1129E02
Root Cause
Labeling False and Misleading
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.