Z-3111-2026 Class II Ongoing
FDA device recall Z-3111-2026 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: 3618.
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
- 3618
Product Description
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);
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): 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;