Atrium Medical recalls specific chest drain valve models due to involvement in a preterm infant's death. Learn which units are affected and safety steps.
The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
Atrium Medical is recalling certain chest drain valves after one was used in the treatment of a preterm infant who later died. This recall highlights a safety issue that requires attention to prevent similar risks.
The device was involved in the treatment of a preterm infant who later died. This indicates a potential safety issue that could lead to serious harm if the device is not properly used or maintained.
Healthcare providers using the Atrium Pneumostat Chest Drain Valve, Part Number 16100, are likely affected. Preterm infants receiving treatment with this device are at the highest risk.
Check for the part number 16100 on the valve. Affected units were sold with specific lot numbers listed in the recall notice.
Look for the lot numbers listed in the recall notice to determine if your valve is affected.
The device was involved in the treatment of a preterm infant who later died, prompting a safety review.
Check the lot number on the valve against the list of affected numbers provided in the recall notice.
The recall does not specify a remedy, so contact Atrium Medical for further guidance.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2592-2021 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2592-2021 from Atrium Medical. 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.
