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Open, Classified

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A

FDA Recall Z-1523-2025 · Posted 2025-04-16

Recalling FirmAvanos Medical, Inc.
Recall StatusOpen, Classified
Product CodeBSY
Date Initiated2025-03-19
Product Quantity9960 units

Reason for Recall

Lack of sterility assurance for closed suction catheter systems

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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