Class IIDeviceOngoing

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);

Reason for recall

An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

Details

Recall number: Z-3111-2026
Event ID: 99680
Recall initiated: Aug 7, 2026
Classified: Sep 4, 2026
Reported: Sep 16, 2026
Quantity: 3618
Distribution: US Nationwide distribution.
Initiated by: Voluntary: Firm initiated
Firm location: Merrimack, NH, United States
Lot / code info: 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;