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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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 Class II 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. 37,310 Z-1922-2013
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