BD Syringe 303344
by Becton, Dickinson and Company
BD Syringe 303344 is a Class II device made by Becton, Dickinson and Company, cleared under FDA 510(k) K021475 on 19 Jul 2002 and listed in FDA GUDID since 11 Sep 2023 (UDI-DI 00382903033447), active as of 26 Oct 2026. 3 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00382903033447 | Date11 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK021475 | Date19 Jul 2002 | StatusActive |
Official records
- AccessGUDID record 00382903033447
- FDA 510(k) database K021475
Across registries
- FDA 510(k) K021475 decided 19 Jul 2002 Active
- FDA GUDID UDI-DI 00382903033447 listed 11 Sep 2023 Listed
Recalls
-
- Terminated Z-0588-2021
BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician.
-
- Terminated Z-0207-2018
Hub damage resulting in breakage and/or leakage during use.
-
- Terminated Z-1009-2012
Becton Dickinson has identified clogged needles.
Timeline
- Cleared FDA 510(k) K021475
- Recall initiated FDA recalls Z-1009-2012
- Recall initiated FDA recalls Z-0207-2018
- Recall initiated FDA recalls Z-0588-2021
- Listed FDA GUDID 00382903033447
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BD Syringe
- Generic name
- General-purpose syringe/needle
- Model / Ref / Catalog
- 303344
- Primary DI / UDI-DI
- 00382903033447
- 510(k) Number
- FDA product code
- JKA, FMI, FMF
- GMDN term
- General-purpose syringe/needle
- Device class
- Class II
- Regulation number
- 862.1675, 880.5570, 880.5860
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under General-purpose syringe/needle.