The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1684-2023·Announced 2023-06-14

AVNS ambIT Catheter System Kits Recalled for Missing Air Filter

Avanos Medical recalls some AVNS ambIT System catheter kits that were potentially distributed without an air in-line filter. Affected units were distributed worldwide, including in Texas, Oregon, and Australia.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with a missing component creating potential risk, but no illnesses, injuries, or deaths reported. The hazard is theoretical without documented adverse events, placing it at the High severity threshold.

Plain-English summary

Avanos Medical, Inc. is recalling certain AVNS ambIT System kits (Product Code 220509) that were potentially distributed without an air in-line filter. A total of 33 cases containing 165 cassettes are affected.

The missing air-in-line filter represents a device defect that creates a potential safety hazard. No illnesses or injuries have been reported in association with this recall.

Affected lot numbers are 30181360 and 30177648, both with expiration dates of December 17, 2023. The recalled units were distributed worldwide, with confirmed distribution in Texas, Oregon, and Australia.

Healthcare facilities and patients who have received these kits should discontinue use and contact Avanos Medical for replacement or guidance. Refer to FDA recall notice Z-1684-2023 for additional details and instructions.

The recalled product

Product
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Manufacturer
Avanos Medical, Inc.
Category
Medical Device — Catheter / Infusion System
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Number (Expiration Date): 30181360 (17 Dec 2023)
  • 30177648 (17 Dec 2023)

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Avanos Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Avanos Medical, Inc.

See all →

Same hazard · missing filter

See all →

Similar recalls