Official recall notice
FDA DeviceClass IINotable
FDA Recall: Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2
- 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): 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;