Vail Products, Inc.
Toledo, OH, US
Vail Products, Inc. appears in FDA device records in Toledo, OH. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 5 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Vail Products, Inc. between 1996 and 1998. The busiest year on record is 1997, with 2. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K982783 | VAIL 1000 ENCLOSED BED | FNL | Substantially Equivalent | |
| K963622 | VAIL 2000 ENCLOSED BED | FNL | Substantially Equivalent | |
| K963589 | VAIL 3000 BED ENCLOSURE | FNL | Substantially Equivalent | |
| K963210 | VAIL 100 PEDIATRIC CRIB | FMS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0863-05 | Vail 2000 Enclosed Bed System. | Risk of patient entrapment, may result in serious injury or death. | Terminated | ||
| Z-0862-05 | Vail 1000 Enclosed Bed System. | Risk of patient entrapment, may result in serious injury or death. | Terminated | ||
| Z-0861-05 | Vail 500 Enclosed Bed System. | Risk of patient entrapment, may result in serious injury or death. | Terminated | ||
| Z-1026-03 | Vail Enclosed Bed System, model 2000 | Patients may become entrapped between the bottom side rail and mattress. | Terminated | ||
| Z-1025-03 | Vail Enclosed Bed System, model 1000 | Patients may become entrapped between the bottom side rail and mattress. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain