Z-3112-2026 Class II Ongoing
FDA device recall Z-3112-2026 was initiated by Atrium Medical Corporation on August 7, 2026 and is designated Class II. Reason for recall: An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. The recall status is ongoing. Affected quantity: 2533.
Recall Details
- Product Type
- Devices
- Report Date
- September 16, 2026
- Initiation Date
- August 7, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2533
Product Description
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);
Reason for Recall
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Distribution Pattern
US Nationwide distribution.
Code Information
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;