Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE — Class II medical device recall Z-0560-2019
Terminated recall by Atrium Medical Corporation, reported 2018-12-12, distributed nationwide. This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containin
| Recall number | Z-0560-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Merrimack, NH, United States |
| Recall initiated | 2018-10-12 |
| Classified | 2018-12-06 |
| Reported by FDA | 2018-12-12 |
| Terminated | 2020-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | SA |
| Quantity | 2,930 units |
| Reason classes | sterility, packaging |
| Model numbers | 8128 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0560-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.