Reported Dec 12, 2018 · Terminated
Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
Atrium Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atrium Medical Corporation · 40 Continental Blvd · Merrimack, NH · 03054-4332
Is this the product you have?
- Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
- Lot codes and dates
- ME221275
- Amount recalled
- 2930 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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