Ballard* Closed Suction System for Adults recallZ-0360-2024 · Avanos Medical, Inc. · initiated Oct 13, 2023
Open, Classified
Is my device affected?
- 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.
- 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.
- 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
Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.
FDA root cause category: Labeling Change Control
What the company is doing
Avanos medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/13/2023 via FedEx. The notice explained the issue, potential risk to health, and requested that the product be destroyed at the consignee. Distributors were directed to notify their customers.
Recall details
- Recall number
- Z-0360-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 13, 2023
- Posted by the FDA
- Nov 21, 2023
- Recalling firm
- Avanos Medical, Inc.
- Quantity
- 4730 cases (94600 devices)
- Product code
- BSY
- Distribution
- US and South Africa
Product description
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Code information (models, lots, serial numbers)
UDI/DI 00609038945064, Lot Numbers: 30112716, 30122936, 30116495, 30122179, 30116496, 30124942, 30117487, 30126227, 30117488, 30124946, 30117632, 30127429, 30117633, 30127494, 30113925, 30137504, 30119101, 30153170, 30119102, 30151042, 30116223, 30194152, 30123991
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ballard* Closed Suction System for Adults 94506Avanos Medical, Inc. · CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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