| Device Type ID | 2640 |
| Device Name | Syringe, Irrigating (non Dental) |
| Regulation Description | Irrigating Syringe. |
| Regulation Medical Specialty | General Hospital |
| 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 | 510(K) Exempt |
| CFR Regulation Number | 880.6960 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KYZ |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2640 |
| Device | Syringe, Irrigating (non Dental) |
| Product Code | KYZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Irrigating Syringe. |
| CFR Regulation Number | 880.6960 [🔎] |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 18 |
Expiration Date Error | 6 |
Disconnection | 5 |
Break | 4 |
Device Disinfection Or Sterilization Issue | 3 |
Device Markings / Labelling Problem | 3 |
Syringe | 3 |
Tip | 3 |
Device Packaging Compromised | 2 |
Unsealed Device Packaging | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Contamination Of Device Ingredient Or Reagent | 1 |
Flaked | 1 |
Gel Leak | 1 |
Misassembled | 1 |
| Total Device Problems | 53 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baxter Healthcare Corporation | II | Mar-01-2018 |
| 2 | C.R. Bard, Inc. | II | Dec-12-2016 |
| 3 | C.R. Bard, Inc. | III | Feb-16-2016 |
| 4 | Cook Inc. | II | Mar-26-2018 |
| 5 | Customed, Inc | II | Apr-14-2016 |
| 6 | Customed, Inc | II | Sep-03-2015 |
| 7 | Shippert Medical Technologies | II | Aug-22-2017 |