Novartis Nutrition Corp.
Minneapolis, MN, US
Novartis Nutrition Corp. appears in FDA device records in Minneapolis, MN. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Novartis Nutrition Corp. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Nestle Healthcare Nutrition, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 6 510(k) clearances for Novartis Nutrition Corp. between 1998 and 2014. The busiest year on record is 1998, with 1. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140947 | COMPAT ENTERAL DELIVERY PUMP SETS | PIF | Substantially Equivalent | |
| K080340 | COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG | KNT | Substantially Equivalent | |
| K071191 | NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT | FPD | Substantially Equivalent | |
| K001916 | COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX | KNT | Substantially Equivalent | |
| K991668 | COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) | KNT | Substantially Equivalent | |
| K981323 | COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE | KNT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1922-2013 | 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. | 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. | Class II | Terminated | |
| Z-0609-03 | Compat DualFlo Enteral Delivery Pump Set with 1000-mL Twist Cap Formula Vinyl Bag and 1000-mL Twist Cap Water Bag, Item number 19944700 | Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern. | Terminated | ||
| Z-0608-03 | Compat 500 mL Baggle Top Fill Enteral Feeding Container with Preattached Enteral Delivery Pump Set, Item number 19931200 | Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern. | Terminated | ||
| Z-0607-03 | Compat Enteral Delivery Pump Set with Piercing Spike, Item number 19930700 | Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain