Avanos recalls specific lots of Ballard Closed Suction Systems for adults due to DEHP contamination in tubing. Affected units may pose health risks if used on patients. Contact Avanos for details.
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.
Avanos is recalling certain lots of their Ballard Closed Suction System for adults because the tubing contains DEHP, a chemical that can be harmful. This risk is especially concerning for patients on mechanical ventilation who use the suction system.
The tubing in certain lots of the Ballard Closed Suction System contains DEHP, a plasticizer that can leach into the suction fluid. This chemical has been linked to health issues when absorbed through the skin or inhaled, particularly in medical settings where the system is used directly on patients.
Patients using the Ballard Closed Suction System for mechanical ventilation are most at risk. Healthcare providers who use the product on adults may also be affected.
Check for the product code 221038 and lot numbers listed: 30112716, 30122936, 30116495, 30122179, 30116496, 30124942, 30117487, 30126227, 30117488, 30124946, 30117632, 30127429, 30117633, 30127494, 30113925, 30137504, 30119101, 30153170, 30119102, 30151042, 30116223, 30194152, 30123991. The product is used for adults on mechanical ventilation.
Identify the product code 221038 and lot numbers listed in the recall notice to determine if your unit is affected.
The recall states that certain lots contain DEHP, which can be harmful. Affected units should be checked against the listed lot numbers before use.
The recall does not specify a remedy, so contact Avanos Medical directly for guidance on next steps.
Check the product code 221038 and lot numbers listed: 30112716, 30122936, 30116495, 30122179, 30116496, 30124942, 30117487, 30126227, 30117488, 30124946, 30117632, 30127429, 30117633, 30127494, 30113925, 30137504, 30119101, 30153170, 30119102, 30151042, 30116223, 30194152, 30123991.
We’ve drafted a message you can send Avanos to request your refund or repair — edit it as you like.
Subject: Recall Z-0360-2024 — Avanos Avanos Hello, I own a Avanos that is covered by recall Z-0360-2024 from Avanos. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
