# K121403: Continuous Peripheral Nerve Block Catheter Kit and Set

- Pathway: 510(k) (Special)
- Applicant: Teleflex, Inc.
- Decided: Jun 20, 2012 after 41 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: 7 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K801912 (1980). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
3 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030937: Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK, Arrow International, Inc. (2003) Summary page 1.

## Most influential descendants
- K122027: Arrow Flexblock Continuous Peripheral Nerve Block Catheter (2012), 2 descendants of its own
- K153652: ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (2016), 0 descendants of its own
- K133316: Spirol  Block (19 GA. Open End Models), (20 GA. Open End Models), (19 GA. Closed End Models), (20 GA. Closed End Models) (2014), 0 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2364-2026: 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 ineffect
- Dec 20, 2019 · Class II · Z-1239-2020: Product lidstock contains the incorrect expiration date for the product
- Dec 20, 2019 · Class II · Z-1253-2020: Product lidstock contains the incorrect expiration date for the product
- Dec 20, 2019 · Class II · Z-1241-2020: Product lidstock contains the incorrect expiration date for the product
- Apr 11, 2018 · Class II · Z-1958-2018: Product sterility may be compromised due to unsealed packaging.
- Nov 10, 2014 · Class II · Z-0573-2015: 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 finish
- Oct 9, 2013 · Class II · Z-0546-2014: 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.

## Indications for use
Continuous nerve block kit and set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

Source page: https://510kreport.com/device/K121403
Methodology: https://510kreport.com/methodology