International Medical Devices Database

Manufacturer Address
Arcadia Medical Corporation, 1140 Millennium Dr, Crown Point IN 46307-7533
Source
USFDA
2 Events
- Recall of Device Recall Silicone CTS Tracheostomy Tube
- Recall of Tracheostomy tubes

2 devices in the database

Device Recall Silicone CTS Tracheostomy Tube

Model / Serial
Lots 00911114 Catalog # 180-060, and Lot 00911116 Catalog # 180-080
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution --USA including the state of Ohio, and the countries of Denmark, Italy, Germany, Turkey, Slovakia, Isreal, France, Sweden, and Romania
Product Description
Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia Medical Silicone Air Cuff Adjustable Tracheostomy Tube, Sterile, Latex-Free, || Provides direct tracheal access for airway management || Arcadia Medical Corporation || 1450 East American Lane, Schaumburg, IL 60173 USA || Arcadia Medical Corporation Tortola, British Virgin Islands || www.arcadiamedical.com, Made in USA

Tracheostomy tubes

Model / Serial
Lot numbers: 01103307 (50 units) and 01107055 (73 units)
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US, including Mariemount, OH and countries of UK and France.
Product Description
Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040. || Intended for use in providing direct tracheal access for airway management.

One manufacturer with a similar name

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Arcadia Medical Corporation

2 devices in the database

Device Recall Silicone CTS Tracheostomy Tube

Tracheostomy tubes

One manufacturer with a similar name

Arcadia Medical Corporation