Smiths Medical
Country not established
- Devices
- 3
- FDA recalls
- 27
At a glance
Market reach
- United States
- FDA recalls
What Smiths Medical makes
Smiths Medical manufactures airway management devices, including percutaneous dilation tracheostomy kits with serial or single-stage dilators, emergency cricothyroidotomy kits, and vibratory positive expiratory pressure (PEP) therapy devices for respiratory support.
These products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) clearance process. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Portex Emergency Cricothyroidotomy Kit Ref K050166
Regimes: 510(k) Registry: 510(k)Acapella Choice Blue Vibratory PEP Device Ref K181660
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 27 recalls initiated by Smiths Medical, the earliest on 2009-08-25 and the most recent on 2011-02-11. By recorded status: 27 terminated. The reasons filed fall into these groups: labeling or instructions for use and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 11 Feb 2011 Z-2647-2011 Unclassified (pre-2012) Terminated A sticky substance on the inside and/ or outside of the Mask
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- 11 Feb 2011 Z-2648-2011 Unclassified (pre-2012) Terminated A sticky substance on the inside and/ or outside of the Mask
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- 11 Feb 2011 Z-2649-2011 Unclassified (pre-2012) Terminated A sticky substance on the inside and/ or outside of the Mask
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- 11 Feb 2011 Z-2650-2011 Unclassified (pre-2012) Terminated A sticky substance on the inside and/ or outside of the Mask
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- 11 Feb 2011 Z-2651-2011 Unclassified (pre-2012) Terminated A sticky substance on the inside and/ or outside of the Mask
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- 11 Feb 2011 Z-2652-2011 Unclassified (pre-2012) Terminated A sticky substance on the inside and/ or outside of the Mask
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- 11 Feb 2011 Z-2653-2011 Unclassified (pre-2012) Terminated A sticky substance on the inside and/ or outside of the Mask
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- 11 Feb 2011 Z-2654-2011 Unclassified (pre-2012) Terminated A sticky substance on the inside and/ or outside of the Mask
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- 11 Feb 2011 Z-2655-2011 Unclassified (pre-2012) Terminated A sticky substance on the inside and/ or outside of the Mask
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- 11 Feb 2011 Z-2656-2011 Unclassified (pre-2012) Terminated A sticky substance on the inside and/ or outside of the Mask
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- 11 Feb 2011 Z-2647-2011 Unclassified (pre-2012) Terminated A sticky substance on the inside and/ or outside of the Mask
Show the 25 most recent of 27 recalls
2009
- 25 Aug 2009 Z-2056-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
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- 25 Aug 2009 Z-2057-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
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- 25 Aug 2009 Z-2058-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
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- 25 Aug 2009 Z-2059-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
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- 25 Aug 2009 Z-2060-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
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- 25 Aug 2009 Z-2061-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
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- 25 Aug 2009 Z-2062-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
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- 25 Aug 2009 Z-2063-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
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- 25 Aug 2009 Z-2064-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
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- 25 Aug 2009 Z-2065-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
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- 25 Aug 2009 Z-2066-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
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- 25 Aug 2009 Z-2067-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
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- 25 Aug 2009 Z-2068-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
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- 25 Aug 2009 Z-2069-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
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- 25 Aug 2009 Z-2070-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
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- 25 Aug 2009 Z-2056-2009 Unclassified (pre-2012) Terminated Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
Frequently asked questions
How many devices does Smiths Medical have in the registry?
The registry currently lists 3 devices for Smiths Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smiths Medical's devices?
Among its 3 most recently registered devices, Smiths Medical has devices listed in FDA 510(k) (3 devices).
What risk classes do Smiths Medical's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Smiths Medical's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Smiths Medical?
FDA recall records list 27 recalls initiated by Smiths Medical, the most recent initiated on 11 Feb 2011. 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 in the registry?
The most recently registered devices listed for Smiths Medical include PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA, PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT and Acapella Choice Blue Vibratory PEP Device.