Novartis Nutrition Corp.
United StatesFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Novartis Nutrition Corp. makes
Novartis Nutrition Corp. manufactures enteral nutrition devices, including replacement gastrostomy tubes, jejunostomy tube kits, and enteral delivery pump sets with integrated spiking systems. Their portfolio includes surgical gastrostomy-jejunostomy feeding tube kits and pre-filled water bags for continuous feeding support.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Compat Dualflo Enteral Delivery Pump Set With Spikeright Piercing Spike And 1000 Ml Waer Bag Ref K080340
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Compat Mini-G Replacement Gastrostomy Tube Ref K981323
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 3 recalls initiated by Novartis Nutrition Corp., initiated on 2003-01-27. By recorded status: 3 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2003
- 27 Jan 2003 Z-0607-03 Unclassified (pre-2012) Terminated 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.
- 27 Jan 2003 Z-0608-03 Unclassified (pre-2012) Terminated 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.
- 27 Jan 2003 Z-0609-03 Unclassified (pre-2012) Terminated 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.
Frequently asked questions
How many devices does Novartis Nutrition Corp. have in the registry?
The registry currently lists 5 devices for Novartis Nutrition Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Novartis Nutrition Corp.'s devices?
Among its 5 most recently registered devices, Novartis Nutrition Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Novartis Nutrition Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Novartis Nutrition Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Novartis Nutrition Corp.?
FDA recall records list 3 recalls initiated by Novartis Nutrition Corp., the most recent initiated on 27 Jan 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Novartis Nutrition Corp. in the registry?
The most recently registered devices listed for Novartis Nutrition Corp. include COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX, COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG, NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT and COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16, 14, OR 12).