FlexTip Plus Epidural Set

• • 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

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

MP-17019-TIP, IPN920763

Primary DI / UDI-DI

14026704737397

Basic UDI-DI

08019020000000000000120K3

510(k) Number

K140110 ↗

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

EUDAMED SRN

US-PR-000023158

• Pressure Injectable One-Lumen PICC

  Class III

  CE/MDR

• Access Kit

  Class IIa

  CE/MDR

• Arterial Catheterization Set

  Class IIb

  CE/MDR

• Femoral Kit

  Class IIb

  CE/MDR

• Tissue Dilator

  Class IIa

  CE/MDR

• Access Set

  Class IIa

  CE/MDR

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