Recall Z-3111-2026 ยท GBZ Catheter, Cholangiography
Atrium Medical Corporation
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);
| Date | Sep 4, 2026 (initiated Aug 7, 2026) |
| Status | Open, Classified |
| 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 |
| Quantity | 3618 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.