The Recall Desk
HighFDA (Devices)·Z-1922-2013·Announced 2013-08-14

Nestle Compat Nasogastric Feeding Tubes Recalled for Sterility Concerns

Nestle HealthCare Nutrition is recalling 37,310 Compat Nasogastric Feeding Tubes because they were delivered in insufficiently sealed pouches, compromising their sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a sterility failure poses a risk of harm (infection) to patients, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Nestle HealthCare Nutrition, Inc. is initiating a recall of 37,310 units of Compat Nasogastric Feeding Tubes in 8 French, 10 French, and 12 French sizes. The recall is being conducted because the products were delivered in insufficiently sealed pouches, which compromises the sterility claimed on the label.

The affected products are distributed nationwide across 33 states, including 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, and WA. Specific lot numbers for each size are listed in the official recall documentation.

These tubes are indicated for the administration of nutrition, fluids, and medications into the stomach or small bowel for patients who have an intact gastrointestinal tract but are physically unable to ingest enough nutrients orally. Consumers and healthcare providers should stop using the affected products and contact Nestle HealthCare Nutrition for further instructions.

The recalled product

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 st
Manufacturer
Nestle HealthCare Nutrition
Category
Medical Device — Enteral Feeding Tubes
Hazard
Affected units
37,310

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 04111P

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Related recalls

Same hazard · sterility compromise

See all →