Z-3113-2026 Class II Ongoing
FDA device recall Z-3113-2026 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: 256.
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
- 256
Product Description
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
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): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;