Official recall notice
FDA DeviceClass IINotable
FDA Recall: Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124)
- Recall date
- 2026-09-16
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Product description
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Affected products
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;