Class IIDeviceOngoing

Atrium Medical Corporation

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.

Details

Recall number: Z-3112-2026
Event ID: 99680
Recall initiated: Aug 7, 2026
Classified: Sep 4, 2026
Reported: Sep 16, 2026
Quantity: 2533
Distribution: US Nationwide distribution.
Initiated by: Voluntary: Firm initiated
Firm location: Merrimack, NH, United States
Lot / code info: 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;