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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description 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.
Recall Number Z-1922-2013
Classification Class II
Code Info 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
Product Distributed Qty 37,310
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.

Event Detail

Event Id 65781
Product Type Devices
Status Ongoing
Recalling Firm Nestle HealthCare Nutrition
City Minnetonka
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.