Vail Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
What Vail Products, Inc. makes
Vail Products, Inc. manufactures enclosed hospital beds and pediatric crib enclosures, including the VAIL 1000, VAIL 2000, VAIL 3000, and VAIL 100 pediatric crib. These products are designed to provide containment and safety for patients within healthcare settings.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. They are based in the United States.
Catalogue
Vail 1000 Enclosed Bed Ref K982783
Regimes: 510(k) Registry: 510(k)Vail 3000 Bed Enclosure Ref K963589
Regimes: 510(k) Registry: 510(k)Vail 2000 Enclosed Bed Ref K963622
Regimes: 510(k) Registry: 510(k)Vail 100 Pediatric Crib Ref K963210
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 5 recalls initiated by Vail Products, Inc., the earliest on 2003-04-01 and the most recent on 2005-05-06. By recorded status: 5 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 6 May 2005 Z-0861-05 Unclassified (pre-2012) Terminated Risk of patient entrapment, may result in serious injury or death.
Full distribution text
- 6 May 2005 Z-0862-05 Unclassified (pre-2012) Terminated Risk of patient entrapment, may result in serious injury or death.
Full distribution text
- 6 May 2005 Z-0863-05 Unclassified (pre-2012) Terminated Risk of patient entrapment, may result in serious injury or death.
Full distribution text
- 6 May 2005 Z-0861-05 Unclassified (pre-2012) Terminated Risk of patient entrapment, may result in serious injury or death.
2003
- 1 Apr 2003 Z-1025-03 Unclassified (pre-2012) Terminated Patients may become entrapped between the bottom side rail and mattress.
- 1 Apr 2003 Z-1026-03 Unclassified (pre-2012) Terminated Patients may become entrapped between the bottom side rail and mattress.
Frequently asked questions
How many devices does Vail Products, Inc. have in the registry?
The registry currently lists 4 devices for Vail Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vail Products, Inc.'s devices?
Among its 4 most recently registered devices, Vail Products, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Vail Products, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Vail Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Vail Products, Inc.?
FDA recall records list 5 recalls initiated by Vail Products, Inc., the most recent initiated on 6 May 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 Vail Products, Inc. in the registry?
The most recently registered devices listed for Vail Products, Inc. include VAIL 1000 ENCLOSED BED, VAIL 3000 BED ENCLOSURE, VAIL 2000 ENCLOSED BED and VAIL 100 PEDIATRIC CRIB.