| Device Type ID | 2850 |
| Device Name | Pad, Alcohol, Device Disinfectant |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | Enforcement Discretion |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LKB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2850 |
| Device | Pad, Alcohol, Device Disinfectant |
| Product Code | LKB |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CATHETER CONNECTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NICE-PAK PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fluid Leak | 25 |
Use Of Device Problem | 9 |
Accessory Incompatible | 4 |
Break | 3 |
Device Contamination With Chemical Or Other Material | 2 |
Appropriate Term/Code Not Available | 2 |
Failure To Unwrap | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Leak / Splash | 1 |
Device Markings / Labelling Problem | 1 |
| Total Device Problems | 49 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Catheter Connections, Inc. | II | Sep-05-2014 |
| 2 | Madison Polymeric Engineering | II | May-12-2017 |