FDA Medical Device Recalls (openFDA)
Atrium Medical Corporation: Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
- Recall number
- Z-3113-2026
- Recalling firm
- Atrium Medical Corporation
- Product
- Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
- Status
- Open, Classified
- Initiated
- 2026-08-07
- Posted
- 2026-09-04
- Terminated
- not on file
- Reason
- An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Root cause
- Nonconforming Material/Component
- Action
- On August 7, 2026 URGENT MEDICAL DEVICE - RECALL letters were sent to customers. Customer Actions: 1. Please examine your inventory immediately to determine if you have any of the Atrium PVC Thoracic Catheters with the specific lot numbers. 2. Should you have any affected product, please remove from area(s) of use and quarantine. 3. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. 4. Please contact Contact Customer Service via email at customersupport.us@getinge.com or 888-943-8872, option 2 / (888 9GETUSA), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. (Eastern Time Zone) to request a return authorization (RMA) and shipping instructions to return any affected product. 5. Whether or not you have affected product(s) within expiration listed in this notice, please complete and sign the attached MEDICAL DEVICE- REMOVAL RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a copy to recallresponses.qrc@getinge.com.
- Quantity
- 256
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;
- 510(k) numbers
- not on file
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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