Official recall notice
FDA DeviceClass IINotable
FDA Recall: Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028),
- 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): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;