Atrium Medical Corporation: Medical Device Recall in 2018 - (Recall #: Z-0560-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 12, 2018

Date Posted: December 12, 2018

Recall Number: Z-0560-2019

Event ID: 81524

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.

Status: Terminated

Product Quantity: 2930 units

Code Information:

ME221275

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated