Atrium Medical recalls specific thoracic catheters due to seal defects in sterile pouches that could cause contamination. Affected units may pose serious infection risks if not properly sealed.
This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect is not detected it could represent a serious hazard to the patient. A sterility breach could potentially lead to product contamination. The potentially affected device is used in contact with critical anatomical structures and deep into the body. If contaminated, the consequences for the patient could be severe. The severity of the possible clinical complications depends on the degree of contamination of the device, the microorganisms involved and the patient s risk factors. To date, Getinge/Atrium has not received any reports of patient injury related to this issue.
Atrium Medical is recalling a specific type of thoracic catheter because some sterile packaging has a seal defect that could lead to contamination. If the packaging isn't properly sealed, the catheter could become contaminated, which might cause serious infections in patients.
The sterile pouches for this catheter have a defect that can cause the pouch to be unsealed at the bottom. If this defect isn't detected, the catheter could become contaminated with bacteria or other pathogens. Contaminated catheters used in deep body procedures might lead to severe infections or other complications.
Healthcare professionals using the Atrium 28Fr PVC Thoracic Catheter Right Angle (Part No. 8128) for medical procedures are most at risk. Patients receiving this device could face serious infections if the catheter becomes contaminated.
Check for the product name 'Atrium 28Fr PVC Thoracic Catheter Right Angle' with part number 8128. The affected units were sold with the model code ME221275.
Inspect the sterile pouch for an unsealed bottom; if present, the device is affected.
No reports of patient injuries have been received by Atrium Medical related to this issue.
Look for the product name 'Atrium 28Fr PVC Thoracic Catheter Right Angle' with part number 8128 and model code ME221275.
Inspect the sterile pouch for an unsealed bottom. If the pouch is unsealed, contact Atrium Medical for 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-0560-2019 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-0560-2019 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.
