FDA Medical Device Recalls (openFDA)
Atrium Medical Corporation: Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
- Recall number
- Z-0560-2019
- Recalling firm
- Atrium Medical Corporation
- Product
- Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
- Status
- Terminated
- Initiated
- 2018-10-12
- Posted
- not on file
- Terminated
- 2020-05-12
- 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.
- 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 catheter2018.us@getinge.com 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
- 2930 units
- Distribution
- Worldwide distribution - US Nationwide distribution, and country of Saudi Arabia.
- Lot, serial or model codes
- ME221275
- 510(k) numbers
- ["K831931"]
- PMA numbers
- not on file
- Product code
- GBZ
- Firm FEI
- 3011175548
- Firm city
- Merrimack
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28