Recall Z-3111-2026
Atrium Medical Corporation · initiated August 7, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
Codes / lots: 1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835; 3. Model Number(Size): 8028(28FR); UDI-DI: 00650862130287; Lot Numbers: ME244682, ME244836, ME244837, ME244681; 4. Model Number(Size): 8032(32FR); UDI-DI: 00650862130324; Lot Number: ME244840; 5. Model Number(Size): 8036(36FR); UDI-DI: 00650862130362; Lot Number: ME244686;
Reason for recall
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-3111-2026
- Initiated
- August 7, 2026
- Posted by FDA
- September 4, 2026
- Product code
- GBZ – Catheter, Cholangiography
- Quantity
- 3618
- Distribution
- US Nationwide distribution.
- Recalling firm
- Atrium Medical Corporation, Merrimack, NH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3112-2026 Class II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1.…An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. | 08/07/2026Open, Classified |
| Z-3113-2026 Class II | Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1.…An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. | 08/07/2026Open, Classified |