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

FDA device recall Z-1521-2025 · posted 2025-04-16 · Open, Classified

Recall details

Recalling firm

Avanos Medical, Inc.

Reason for recall

Lack of sterility assurance for closed suction catheter systems

Action taken

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 productquality@myairlife.com. 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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

BSY

Quantity affected

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

Date initiated

2025-03-19

Date posted

2025-04-16

Location

Alpharetta, GA