Z-1189-2023Class I

BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold

Name: Z-1189-2023 BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold
Creator: Avanos Medical, Inc.
Published: 2023-02-03
License: https://open.fda.gov/license/

Halyard Health / initiated 2023-02-03 / Terminated / root cause: design

FDA source

Avanos Medical, Inc. began a recall of BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold on 2023-02-03. FDA classified it as Class I and gives the reason as "Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1189-2023
Classification: Class I
Status: Terminated
Initiated: 2023-02-03
Posted: 2023-03-13
Terminated: 2024-09-05
Recalling firm: Halyard Health
Product: BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
Product code: BSY Catheters, Suction, Tracheobronchial
Reason for recall: Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
Root cause tag: design
FDA root cause: Component design/selection
Action: Avanos hand-delivered the recall notification to the single consignee on 02/03/2023. The letter instructed the customer to discontinue use of and quarantine their stock of all lots of affected units and return them. Additionally, the customer was instructed to complete and return the acknowledgement form.
Quantity in commerce: 780 units
Distribution: US Nationwide distribution in the state of Oklahoma.
Product codes and lots: All lots are affected. Stock Code (Lot Number): B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), B31011 (20098363).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1189-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1189-2023	Class I	Terminated	Voluntary: Firm initiated	2023-03-22	2023-03-13
Z-1190-2023	Class I	Terminated	Voluntary: Firm initiated	2023-03-22	2023-03-13

Product code BSY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)