Z-1521-2025Class I

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A...

Name: Z-1521-2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A...
Creator: Avanos Medical, Inc.
Published: 2025-03-19
License: https://open.fda.gov/license/

Halyard Health / initiated 2025-03-19 / Open, Classified / root cause: sterility

FDA source

Avanos Medical, Inc. began a recall of Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System... on 2025-03-19. FDA classified it as Class I and gives the reason as "Lack of sterility assurance for closed suction catheter systems". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1521-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-03-19
Posted: 2025-04-16
Recalling firm: Halyard Health
Product: Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No
Product code: BSY Catheters, Suction, Tracheobronchial
Reason for recall: Lack of sterility assurance for closed suction catheter systems
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: On March 19, 2025, AirLife, legal manufacturer for Avanos issued a "Urgent Medical Device Recall" Notification to affected consignees via E-Mail. Avanos asked consignees to take the following actions: a. Review the list of affected products. Please examine your inventory for the mentioned lot(s). b. Immediately, stop/cease use and quarantine all affected product. c. Please complete and return the attached Response Form via e-mail to [email protected]. d. if you have further distributed this product, please identify your customers/consignees, and notify them of this product removal. e. Once you return and/or confirm destruction of the affected product(s), new replacement product will be sent to you. If you need replacement products to be sent to you urgently, please call AirLife directly at 1-800-433-2797 and we will make every effort to accommodate your needs. f. Please make sure that all affected personnel in your organization are informed of this removal notice.
Quantity in commerce: 1980 units
Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN,KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of South Korea, New Zealand, Canada, Mexico, Germany, England, Slovenia, France, Austria, Guadalajara.
Product codes and lots: Lot Code: Lot/ Serial Number(s): 1561168 Each: 00609038938264 DSP: 10609038938261 Case: 20609038938268

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1521-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1521-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-16
Z-1522-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-16
Z-1523-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-16
Z-1524-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-16
Z-1525-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-16
Z-1526-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-16
Z-1527-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-16
Z-1528-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-16

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)