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Ballard* Closed Suction System for Adults recallZ-1525-2025 · Avanos Medical, Inc. · initiated Mar 19, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Avanos Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Lack of sterility assurance for closed suction catheter systems

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1525-2025
Status
Open, Classified
Initiated by the company
Mar 19, 2025
Posted by the FDA
Apr 16, 2025
Recalling firm
Avanos Medical, Inc.
Quantity
2080 units
Product code
BSY
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 description

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A

Code information (models, lots, serial numbers)

Lot Code: Lot/ Serial Number(s): 1555424 Each: 00609038983103 DSP: 10609038983107 Case: 20609038983100

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 96528).

Sources and updates

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