Z-0560-2019Class II

Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128

Name: Z-0560-2019 Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
Creator: Atrium Medical Corporation
Published: 2018-10-12
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2018-10-12 / Terminated / root cause: supplier

FDA source

Atrium Medical Corporation began a recall of Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128 on 2018-10-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0560-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-12
Posted: 2018-12-06
Terminated: 2020-05-12
Recalling firm: Atrium Medical Corporation
Product: Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
Product code: GBZ Catheter, Cholangiography
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.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: The firm notified affected customers on October 29, 2018 via an Urgent Medical Device Recall letter. The letter alerted customers to the issue of the product's sterile barrier pouch not being properly sealed at the bottom. Customers were asked to do the following: 1. Examine your inventory to determine if you have the affected product listed in this Notification. If so, remove affected products, quarantine them, and place in a secure location. 2. If you have affected product, contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm (EST), for a Return Authorization (RA) to return the product for replacement or credit. 3. Complete and sign the enclosed Medical Device - Recall Response Form on Page 4 of this letter to acknowledge receipt of this notification. If you have affected product to return, enter the quantity and your RA number in the space provided. 4. Return the completed Medical Device - Recall Response Form to: EMAIL [email protected] or FAX 1-973-807-1654. If you have any questions, please contact your Getinge/Maquet representative or call Maquet Customer Service at 1-603-880-1433, Monday through Friday between the hours of 9:00 am to 5:00 pm Eastern Time Zone.
Quantity in commerce: 2930 units
Distribution: Worldwide distribution - US Nationwide distribution, and country of Saudi Arabia.
Product codes and lots: ME221275

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0560-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0560-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-12-06

Product code GBZ

K831931Class IAtrium Thoracic CatheterAtrium Medical Corp. / cleared 1983-10-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)