Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number)
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
Why it was recalled
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
What to do
The recall is ongoing. Follow the firm and FDA instructions.
Affected products and identifiers
1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850; — 256
Record details
Atrium Medical Corporation — US Nationwide distribution.