Device recall
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);
- Recall number
- Z-3111-2026
- 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
- 3618
- 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;
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Merrimack, NH, United States