Recall Z-0560-2019— Atrium Medical Corporation

Name: FDA recall Z-0560-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-12

Class II · Terminated

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2018-10-12, terminated 2020-05-12. It names one FDA 510(k) clearance: K831931. Product: Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128. Reason: 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..

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-10-12
Terminated: 2020-05-12
Firm location: Merrimack, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K831931 — ATRIUM THORACIC CATHETERAtrium Medical Corp.·cleared 1983-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.