Atrium Medical Corporation recalls Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128

Recall date

October 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0560-2019

FDA classification

Class II

Brand / firm

Atrium Medical Corporation

Sold / distributed

Worldwide distribution - US Nationwide distribution, and country of Saudi Arabia.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128