FLEXTIP PLUS EPIDURAL CATHETER - Flextip Plus Epidural Catheter

• • 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

510(k) Number

K140110 ↗

FDA Product Code

BSO

Models / Variants

Flextip Plus Epidural Catheter

flexblock Continous Peripheral Nerve Block Catheter Kit/Set

Device Class

Class II

Regulation

21 CFR Part 868.5120

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Percutaneous Introducer Kit

  Class II

  FDA 510(k) K123974 Active Cleared 21 Feb 2013

• Conchasmart Breathing Circuit

  Class II

  FDA 510(k) K140556 Active Cleared 24 Sep 2014

• ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set

  Class II

  FDA 510(k) K153652 Active Cleared 21 Jun 2016

• Peel Away & Split Sheath Percu Cath Introducer Set

  Class II

  FDA 510(k) K860307 Active Cleared 20 May 1986

• Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart Column

  Class II

  FDA 510(k) K131912 Active Cleared 6 Mar 2014

• Conchasmart Column

  Class II

  FDA 510(k) K141940 Active Cleared 24 Nov 2014

See all devices from Teleflex LLC →