BD Luer-Lok 309571: CE/MDR Class IIa

Regulatory status

as of registry sync 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number038290OGBPJDLC74 Basic UDI-DI 00382903095711UDI-DI	Date12 Aug 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00382903095711 UDI-DI	Date19 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK110771	Date13 May 2011Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 038290OGBPJDLC74 — open Devices and search for it
AccessGUDID record UDI-DI 00382903095711
FDA 510(k) database 510(k) number K110771

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 038290OGBPJDLC74 registered 12 Aug 2026 Active
FDA 510(k) K110771 decided 13 May 2011 Active
FDA GUDID UDI-DI 00382903095711 listed 19 Sep 2016 Listed

Recalls

10 recalls · 1 ongoing · FDA

- Ongoing Z-2614-2026 FDA Class II initiated 28 Apr 2026
A single lot of expired syringes were distributed due to a distribution system control failure.
5 recalls, same reason
- Terminated Z-2753-2017 FDA Class II initiated 16 Sep 2016
- Terminated Z-2747-2017 FDA Class II initiated 16 Sep 2016
- Terminated Z-2752-2017 FDA Class II initiated 16 Sep 2016
- Terminated Z-2750-2017 FDA Class II initiated 16 Sep 2016
- Terminated Z-2749-2017 FDA Class II initiated 16 Sep 2016
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
- Terminated Z-2751-2017 FDA Class II initiated 16 Sep 2016
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required of 10-6.
2 recalls, same reason
- Terminated Z-1936-2016 FDA Class II initiated 25 Mar 2016
- Terminated Z-1937-2016 FDA Class II initiated 25 Mar 2016
BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.
- Terminated Z-1055-2015 FDA Class II initiated 19 Dec 2014
The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.

Timeline

13 dated events

25 Mar 2016 Recall initiated FDA recalls Z-1937-2016
16 Sep 2016 Recall initiated FDA recalls Z-2753-2017
16 Sep 2016 Recall initiated FDA recalls Z-2747-2017
16 Sep 2016 Recall initiated FDA recalls Z-2752-2017
16 Sep 2016 Recall initiated FDA recalls Z-2751-2017
16 Sep 2016 Recall initiated FDA recalls Z-2750-2017
16 Sep 2016 Recall initiated FDA recalls Z-2749-2017
19 Sep 2016 Listed FDA GUDID 00382903095711
28 Apr 2026 Recall initiated FDA recalls Z-2614-2026
12 Aug 2026 Registered EUDAMED 038290OGBPJDLC74

3 earlier events are in the sections above.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Plastipak Luer-Lok EUDAMED
BD Luer-Lok GUDID
Generic name: General-purpose syringe/needle
Device name: BD Plastipak™ Syringe Luer-Lok™ Tip with BD PrecisionGlide™ Needle
Model / Ref / Catalog: 309571

Primary DI / UDI-DI: 00382903095711
Basic UDI-DI: 038290OGBPJDLC74
510(k) Number: K110771
FDA product code: FMF
EMDN code: A0101010102 Hypodermic syringe needles, w/o safety systems
GMDN term: General-purpose syringe/needle

Device class: Class IIa EUDAMED
Class II GUDID
Regulation number: 880.5860
EU registration type: Standard device
EU market of registration: Spain
GUDID distribution status: In Commercial Distribution

Size: Needle Gauge — 23 Gauge
Total Volume — 3 Milliliter
Length — 1 Inch

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIa	GUDID Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.