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FlexTip Plus Epidural Set

by Arrow International LLC (Subsidiary of Teleflex Incorporated) United States EUDAMEDGUDID

Ref EC-05400-E

Product code BSOEMDN N02010199

Regulatory status

as of 24 Oct 2026

Recall ongoing. 3 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number14026704737403 UDI-DIDate30 Jul 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number08019020000000000000120K3 Basic UDI-DIDate2 Apr 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

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

Specification

EUDAMED · GUDID · synced 23 Oct 2026

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, IPN920766
Primary DI / UDI-DI
14026704737403
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
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
EC-05400-E
GUDID
IPN920766
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 & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (8)
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (2)

  • EUDAMED 25c9edd3-65c4-418b-af4a-6ecb50088c1e 61 fields · synced 23 Oct 2026
  • FDA UDI acbad3a3-cf21-4adb-8743-c2fc84dbe782 35 fields · synced 23 Oct 2026