The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1189-2023·Announced 2023-03-22

BALLARD ACCESS Closed Suction System Manifold May Crack and Leak

Avanos Medical is recalling 780 units of the BALLARD ACCESS Closed Suction System due to manifold cracking that can leak the respiratory circuit, potentially causing 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: This product is classified by the FDA as Class I, which requires a minimum severity score of 4 (Severe). The potential for manifold cracking and resulting respiratory circuit leaks poses serious risks of inadequate ventilation in vulnerable neonatal and pediatric patients.

Plain-English summary

Avanos Medical, Inc. is recalling the BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold. This recall affects 780 units. All affected lots are included: B30511, B30611, B30711, B30811, and B31011.

The recalled product's manifold may crack during use. When the manifold cracks, it can cause leaks in the respiratory circuit, potentially resulting in patients receiving inadequate ventilation. For neonatal and pediatric patients, inadequate ventilation presents serious health risks.

Healthcare facilities and providers currently using this product should discontinue use immediately and contact Avanos Medical, Inc. for instructions on obtaining replacement units.

The recalled product

Product
BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Manufacturer
Avanos Medical, Inc.
Category
Medical Device — Respiratory / Suction System
Hazard
Affected units
780

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): B30511 (20098360)
  • B30611 (20098361)
  • B30711 (20097200)
  • B30811 (20098362)
  • B31011 (20098363).

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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