FDA recall Z-0560-2019

Product

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-10-12

Report date

2018-12-12

Termination date

2020-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Merrimack, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0560-2019