Z-3112-2026Class II

Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2...

Name: Z-3112-2026 Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2...
Creator: Atrium Medical Corporation
Published: 2026-08-07
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2026-08-07 / Open, Classified / root cause: manufacturing process

FDA source

Atrium Medical Corporation began a recall of Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136) on 2026-08-07. The reason FDA records is "An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3112-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-07
Posted: 2026-09-04
Recalling firm: Atrium Medical Corporation
Product: Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);
Product code: GBZ Catheter, Cholangiography
Reason for recall: An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 [email protected].
Quantity in commerce: 2533
Distribution: US Nationwide distribution.
Product codes and lots: 1. Model Number(Size): 8124(24FR); UDI-DI: 00650862132243; Lot Number: ME244852; 2. Model Number(Size): 8128(28FR); UDI-DI: 00650862132281; Lot Number: ME244854, ME244855; 3. Model Number(Size): 8132(32FR); UDI-DI: 00650862132328; Lot Numbers: ME244565, ME244858, ME244859; 4. Model Number(Size): 8136(36FR); UDI-DI: 00650862132366; Lot Number: ME244861;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3112-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3111-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-16	2026-09-04
Z-3112-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-16	2026-09-04
Z-3113-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-16	2026-09-04

Product code GBZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-12. View this recall on fda.gov (opens on fda.gov)