Devices

Alta Gold

Model / Serial
Al lot codes
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
Product Description
55CM ALTA LR GOLD STD KIT || Model: ALC50SH55 || ALTA GOLD || 15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and || apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr || dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.
Manufacturer
Spire Biomedical, Inc.
1 Event
- Recall of Alta Gold

Manufacturer

Spire Biomedical, Inc.

Manufacturer Address
Spire Biomedical, Inc., One Patriots Park, Bedford MA 01730-2343
Manufacturer Parent Company (2017)
Spire Corporation
Source
USFDA

One device with a similar name

Learn more about the data here

Alta Gold

Model / Serial
All lot codes
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
Product Description
40CM ALTA LR GOLD STD KIT || Model: ALC35SH40 || ALTA GOLD || 15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and || apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr || dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.
Manufacturer
Spire Biomedical, Inc.

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

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.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)