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FlexTip Plus Epidural Set

by Arrow International LLC (Subsidiary of Teleflex Incorporated) 7 variants

Ref EC-05400-E

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08019020000000000000120K3 Basic UDI-DIDate2 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14026704737410 UDI-DIDate9 Nov 2022ListedStatusListed GUDID: in commercial distribution

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

9 recalls · 3 ongoing · FDA

    • Ongoing Z-2371-2026 FDA Class I initiated 21 Apr 2026

    Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

    • Ongoing Z-1913-2026 FDA Class II initiated 11 Mar 2026

    Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

    • Ongoing Z-2288-2020 FDA Class II initiated 8 May 2020

    Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.

  • 3 recalls, same reason

    • Terminated Z-1174-2020 FDA Class II initiated 15 Jan 2020
    • Terminated Z-1177-2020 FDA Class II initiated 15 Jan 2020
    • Terminated Z-1172-2020 FDA Class II initiated 15 Jan 2020

    There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.

  • 3 recalls, same reason

    • Terminated Z-1238-2020 FDA Class II initiated 20 Dec 2019
    • Terminated Z-1236-2020 FDA Class II initiated 20 Dec 2019
    • Terminated Z-1237-2020 FDA Class II initiated 20 Dec 2019

    Product lidstock contains the incorrect expiration date for the product

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade Name
FlexTip Plus Epidural Set EUDAMED
Arrow GUDID
Generic Name
Epidural anaesthesia set, non-medicated
Device Name
Anesthesia Procedure Packs - Catheters
Model / Ref / Catalog
EC-05400-E, IPN920767
Primary DI / UDI-DI
14026704737410
Basic UDI-DI
08019020000000000000120K3
510(k) Number
FDA Product Code
BSO
EMDN Code
N02010199 Peridural / epidural spinal catheters and kits - other
GMDN Term
Epidural anaesthesia set, non-medicated
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
868.5120
Medical Purpose
The procedure packs contain CE-marked medical devices, which are packaged together and shipped to a customer upon request for physician/medical professional use. The devices can be used together or used individually. Epidural catheter permits access to the epidural space for the administration of epidural anaesthetic
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
EC-05400-E
GUDID
IPN920767
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-PR-000023158

Other devices from Arrow International LLC (Subsidiary of Teleflex Incorporated)

See all devices from Arrow International LLC (Subsidiary of Teleflex Incorporated) →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No