The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1190-2023·Announced 2023-03-22

Closed Suction System Manifold Cracking Poses Respiratory Circuit Leak Risk

Avanos Medical recalls BALLARD ACCESS Closed Suction System units due to manifold cracking, which can cause respiratory circuit leaks and inadequate ventilation in neonatal and pediatric patients.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification mandates a minimum severity of Severe. The defect—manifold cracking—can cause respiratory circuit leaks leading to inadequate ventilation in vulnerable neonatal and pediatric patients, though no illnesses or injuries have been reported.

Plain-English summary

Avanos Medical, Inc. is recalling 220 units of the BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold. The recall covers all affected lots and stock codes as identified by the manufacturer.

The recalled device component can crack during use on patients. Cracking in the manifold can cause leaks in the respiratory circuit, potentially leading to inadequate ventilation.

The device is intended for neonatal and pediatric respiratory care. Patients relying on affected units may not receive adequate ventilation if manifold cracking occurs during treatment.

For more information about the recall, including affected lot numbers and stock codes, contact Avanos Medical, Inc. or the FDA's Medical Devices division.

The recalled product

Product
BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
Manufacturer
Avanos Medical, Inc.
Category
Medical Device — Respiratory / Airway Management
Hazard
Affected units
220

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 (5)

  • All lots are affected. Stock Code (Lot Number): B50511 (20098277)
  • B50611 (20098278)
  • B50711 (20098279)
  • B50811 (20097177
  • 20097177R1).

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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