| ||Class 2 Device Recall Compat Nasogastric Feeding Tube |
||August 06, 2013
||Terminated on June 13, 2014
|Recall Event ID
Tube, feeding -
||Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500).
The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition, fluids and medications into the stomach r small bowel by the naso-enteric, route for patients who have an intact gastrointestinal tract but are physically unable to ingest enough nutrients orally to meet their current needs.
||REF 08310400 - Compat¿ Nasogastric Feeding Tube 8 French (8Fr) in the following lots:
REF 08310500- Compat¿ Nasogastric Feeding Tube 12 French (12Fr) in the following lots:
04111D, 04111P, 04111V
REF 08310600 - Compat¿ Nasogastric Feeding Tube 10 French (10Fr) in the following lots:
Nestle HealthCare Nutrition
12500 Whitewater Dr
|For Additional Information Contact
|Nestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes because they have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label.
|Packaging process control
||Nestle Health Science sent a "Medical Device Recall" letter dated July 24, 2013. The letter was addressed to Risk Manger. The letter described the product involved, problem and actions to be taken. Customers were advised that products currently in use should not be returned. Customers were requested to examine their inventory, quarantine the product, carry the recall to the user facility level and to complete and return the Acknowledgment / Response Form.
For questions call Nestle HealthCare Nutrition Customer Service at 1-877-463-7853.
|Quantity in Commerce
||US Nationwide Distribution - including the states of: AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = FPD and Original Applicant = SANDOZ NUTRITION