Device recall
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);
- Recall number
- Z-3112-2026
- 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
- 2533
- 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;
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Merrimack, NH, United States