Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198…
Reason for recall
Lack of sterility assurance for closed suction catheter systems
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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: No4 affected lots1561168006090389382641060903893826120609038938268
What the firm 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 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.
DistributionShow detailsHide
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.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1521-2025
- FDA device classification · BSYOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.6810The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Avanos Medical, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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