Z-0560-2019 Class II Terminated
FDA device recall Z-0560-2019 was initiated by Atrium Medical Corporation on Oct 12, 2018 and is designated Class II. 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… The recall status is terminated (terminated May 12, 2020). Affected quantity: 2930 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 12, 2018
- Initiation Date
- Oct 12, 2018
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2930 units
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution, and country of Saudi Arabia.
Code Information
ME221275
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0560-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026