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N/A 300912

by Becton, Dickinson and Company EUDAMEDGUDID

Active European Union Open recall

Ref 300912

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038290RGRRRCDXJ8 Basic UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382903009121 UDI-DIDate16 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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.

Specification

EUDAMED · GUDID

Trade Name
Luer-Lok
Generic Name
General-purpose syringe, single-use
Device Name
BD Syringes
Model / Ref / Catalog
300912
Primary DI / UDI-DI
00382903009121
Basic UDI-DI
038290RGRRRCDXJ8
510(k) Number
FDA Product Code
FMF
EMDN Code
A020102020102 Infusion and irrigation syringes, luer lock cone, 3-piece without needle, single-use
GMDN Term
General-purpose syringe, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5860
Market of Registration
Poland
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 10 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: General-purpose syringe, single-use

Cleared under the same submission (K110771)

Show all (12)

Other devices from Becton, Dickinson and Company

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Properties

  • Sterile
  • Single Use
  • Administering Medicine
  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No