Z-0845-2022Class II

BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP)...

Name: Z-0845-2022 BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP)...
Creator: Avanos Medical, Inc.
Published: 2021-11-22
License: https://open.fda.gov/license/

Halyard Health / initiated 2021-11-22 / Terminated / root cause: labeling and UDI

FDA source

Avanos Medical, Inc. began a recall of BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use on 2021-11-22. FDA classified it as Class II and gives the reason as "Product was distributed with incorrect expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0845-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-22
Posted: 2022-03-31
Terminated: 2023-01-31
Recalling firm: Halyard Health
Product: BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use
Product code: BSY Catheters, Suction, Tracheobronchial
Reason for recall: Product was distributed with incorrect expiration date.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The firm sent out a Urgent Advisory Notice dated 11/22/2021 via email to consignees notifying them of recall and identifying affected lots. Consignees were informed to check their unused inventory for affected product, and to subsequently quarantine and destroy any recalled product. Additionally, consignees were provided with a Recall Acknowledgement Form that was to be completed within five business days of receipt and returned to [email protected]. Consignees that have used recalled product and have no additional units in stock are instructed to complete the Recall Acknowledgement Form indicating that they have no inventory of impacted products.
Quantity in commerce: 20 devices (1 case)
Distribution: Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.
Product codes and lots: Finished Product Code: 102008602; Alternate Code: 24013-5; Lot No.: 30143745.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0845-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0845-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-06	2022-03-31
Z-0846-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-06	2022-03-31
Z-0847-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-06	2022-03-31

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)