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U.S. Department of Health and Human Services

Class 2 Device Recall Compat Nasogastric Feeding Tube

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  Class 2 Device Recall Compat Nasogastric Feeding Tube see related information
Date Initiated by Firm July 24, 2013
Date Posting Updated August 06, 2013
Recall Status1 Terminated 3 on June 13, 2014
Recall Number Z-1922-2013
Recall Event ID 65781
510(K)Number K915439  
Product Classification Tube, feeding - Product Code FPD
Product Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500).

Product Usage:
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.

Code Information REF 08310400 - Compat¿ Nasogastric Feeding Tube 8 French (8Fr) in the following lots:, 01413G , 02412K, 08211Z, 08712W, 14212U, 14611P, 21512Y, 35411H

REF 08310500- Compat¿ Nasogastric Feeding Tube 12 French (12Fr) in the following lots:, 01211AV, 01513N , 04111D, 04111P, 04111V, 05812F, 05912F, 06313N, 21512G, 23412BV, 34712V, 35411U

REF 08310600 - Compat¿ Nasogastric Feeding Tube 10 French (10Fr) in the following lots:, 08111M, 08712D, 10211E, 13712W, 21512F, 05312N.
Recalling Firm/
Nestle HealthCare Nutrition
12500 Whitewater Dr
Minnetonka MN 55343-9420
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Packaging process control
Action 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 37,310
Distribution 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPD and Original Applicant = SANDOZ NUTRITION