FDA Devices recall · Reported December 12, 2018
Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
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 p…
Atrium Medical Corporation recalled Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128 - a moderate-severity action.
Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128 was recalled by Atrium Medical Corporation in December 12, 2018. Reason: This recall has been initiated in response to a seal defect found in certain sterile barrier pouches contain…. Check the official notice for the remedy. Verify recall #Z-0560-2019 with the FDA Devices before acting.
The recall
Atrium Medical Corporation issued this moderate-severity FDA Devices recall-This recall has been initiated in response to a seal defect found in certain sterile barrier pouches contain….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- December 12, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0560-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0560-2019 |
| Date reported | December 12, 2018 |
| Date initiated | October 12, 2018 |
| Recalling firm | Atrium Medical Corporation |
| Firm location | Merrimack, NH |
| Affected scope | 2930 units |
| Distribution | Worldwide distribution - US Nationwide distribution, and country of Saudi Arabia. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0560-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026