Device recall
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
- Recall number
- Z-3113-2026
- Event id
- 99680
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Atrium Medical Corporation
- Report date
- Sep 16, 2026
- Posted
- Sep 4, 2026
- Initiated
- Aug 7, 2026
- Center classification date
- Sep 4, 2026
- Product code
- GBZ
- Device type
- Catheter, Cholangiography
- Reason
- An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Root cause
- Nonconforming Material/Component
- Quantity
- 256
- Code info
- 1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Merrimack, NH, United States