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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 Recall
Compat Nasogastric Feeding Tube
see related information
Date Posted August 06, 2013
Recall Status1 Open
Recall Number Z-1922-2013
Recall Event ID 65781
Premarket Notification
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/
Manufacturer
Nestle HealthCare Nutrition
12500 Whitewater Dr
Minnetonka, Minnesota 55343-9420
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 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) Database 510(K)s with Product Code = FPD and Original Applicant = SANDOZ NUTRITION
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