# FDA recall Z-0560-2019

> **Atrium Medical Corporation** · Class II · device recall initiated 2018-10-12.

## 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

- **Recall number:** Z-0560-2019
- **Recalling firm:** Atrium Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0560-2019. Retrieved 2026-06-15 from https://api.ai-analytics.org/recall/Z-0560-2019. Source: US FDA. Licensed CC0.

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