Arrow IPN029630

• FDA 510(k) K121403 decided 20 Jun 2012 Active
• FDA GUDID UDI-DI 10801902143768 listed 24 Oct 2018 Listed

• • Ongoing Z-2364-2026 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.

• 3 recalls, same reason

  • Terminated Z-1253-2020 FDA Class II ·initiated 20 Dec 2019
  • Terminated Z-1241-2020 FDA Class II ·initiated 20 Dec 2019
  • Terminated Z-1239-2020 FDA Class II ·initiated 20 Dec 2019

  Product lidstock contains the incorrect expiration date for the product

• • Terminated Z-1958-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

• • Terminated Z-0573-2015 FDA Class II ·initiated 10 Nov 2014

  Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. The product lidstock incorrectly identifies the needle in the finished good as 17Ga rather than the correct 18Ga. The product included in the package is the correct 18Ga size. No injuries or illnesses have been reported.

• • Terminated Z-0546-2014 FDA Class II ·initiated 9 Oct 2013

  A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin.

1. 20 Jun 2012 Cleared FDA 510(k) K121403
2. 9 Oct 2013 Recall initiated FDA recalls Z-0546-2014
3. 10 Nov 2014 Recall initiated FDA recalls Z-0573-2015
4. 11 Apr 2018 Recall initiated FDA recalls Z-1958-2018
5. 24 Oct 2018 Listed FDA GUDID 10801902143768
6. 20 Dec 2019 Recall initiated FDA recalls Z-1253-2020
7. 20 Dec 2019 Recall initiated FDA recalls Z-1241-2020
8. 20 Dec 2019 Recall initiated FDA recalls Z-1239-2020
9. 21 Apr 2026 Recall initiated FDA recalls Z-2364-2026

Trade name

Arrow

Generic name

Epidural anaesthesia set, non-medicated

Model / Ref / Catalog

IPN029630, ASK-05060-SM

Primary DI / UDI-DI

10801902143768

510(k) Number

K121403 ↗

FDA product code

CAZ

GMDN term

Epidural anaesthesia set, non-medicated

Device class

Class II

Regulation number

868.5140

GUDID distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Category: Epidural anaesthesia set, non-medicated

Other devices filed under FDA product code CAZ (Anesthesia conduction kit).

• Profoject™ LOR Syringe by CMT Health PTE., Ltd.
• FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER by Teleflex LLC
• Local Plexus Block Anesthesia Catheter Kits by PREFERRED MEDICAL PRODUCTS, LLC
• Contiplex Continuous Nerve Block Set by B. Braun Medical, Inc.
• Sensi-Touch Epidural Anesthesia Tray by Sherwood Medical Co.
• MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT by Mega Medical, Inc.
• VPC by Pajunk GmbH Medizintechnologie
• Continuous Epidural Anesthesia Tray by Medsurg Industries, Inc.
• Kendall Safetrak Combined Epidural/Spinal Kit by Kendall Healthcare Products Co. Div.Of Tyco Health
• Arrow Epidural Catheter Kit by Teleflex Medical, LLC

• Arrow IPNB00820 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00826 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00822 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00827 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

See all devices from Teleflex Incorporated →