FDA Device recall Z-0560-2019
Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
- FDA Device
- Class II
- terminated
- Published 2018-12-12
On 2018-12-12 the FDA classified a Class II recall of Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128 by Atrium Medical, citing 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 po….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0560-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-12 |
| Published | 2018-12-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Atrium Medical |
| Distribution | US |
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.
Identifiers
| code_info | ME221275 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0560-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.