Z-0360-2024Class II

AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on...

Name: Z-0360-2024 AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on...
Creator: Avanos Medical, Inc.
Published: 2023-10-13
License: https://open.fda.gov/license/

Halyard Health / initiated 2023-10-13 / Open, Classified / root cause: labeling and UDI

FDA source

Avanos Medical, Inc. began a recall of AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation on 2023-10-13. FDA classified it as Class II and gives the reason as "Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0360-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-13
Posted: 2023-11-21
Recalling firm: Halyard Health
Product: AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Product code: BSY Catheters, Suction, Tracheobronchial
Reason for recall: Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Avanos medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/13/2023 via FedEx. The notice explained the issue, potential risk to health, and requested that the product be destroyed at the consignee. Distributors were directed to notify their customers.
Quantity in commerce: 4730 cases (94600 devices)
Distribution: US and South Africa
Product codes and lots: UDI/DI 00609038945064, Lot Numbers: 30112716, 30122936, 30116495, 30122179, 30116496, 30124942, 30117487, 30126227, 30117488, 30124946, 30117632, 30127429, 30117633, 30127494, 30113925, 30137504, 30119101, 30153170, 30119102, 30151042, 30116223, 30194152, 30123991

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0360-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0360-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-20

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)