Smiths Medical International, Ltd.
Country not established
- Devices
- 5
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Smiths Medical International, Ltd. makes
Smiths Medical International, Ltd. makes medical devices such as percutaneous tracheostomy kits and ventilator devices, including the PORTEX PERCUTANEOUS TRACHEOSTOMY KIT and various PNEUPAC models.
The company's portfolio is regulated as Class II devices and is listed in the FDA 510(k) registry, with the company based in the US.
Catalogue
Portex Percutaneous Tracheostomy Kit Ref K060945
Regimes: 510(k) Registry: 510(k)Babypac Ref K043495
Regimes: 510(k) Registry: 510(k)Pneupac VR1 Air Mix Ref K071527
Regimes: 510(k) Registry: 510(k)Pneupac Parapac Plus Ref K123957
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Smiths Medical International, Ltd., initiated on 2005-06-07. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 7 Jun 2005 Z-0961-05 Unclassified (pre-2012) Terminated Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label
Frequently asked questions
How many devices does Smiths Medical International, Ltd. have in the registry?
The registry currently lists 5 devices for Smiths Medical International, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smiths Medical International, Ltd.'s devices?
Among its 5 most recently registered devices, Smiths Medical International, Ltd. has devices listed in FDA 510(k) (5 devices).
What risk classes do Smiths Medical International, Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Smiths Medical International, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Smiths Medical International, Ltd.?
FDA recall records list 1 recall initiated by Smiths Medical International, Ltd., the most recent initiated on 7 Jun 2005. 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 Smiths Medical International, Ltd. in the registry?
The most recently registered devices listed for Smiths Medical International, Ltd. include PORTEX PERCUTANEOUS TRACHEOSTOMY KIT, BABYPAC, PNEUPAC VR1 AIR MIX and PNEUPAC PARAPAC PLUS.