TemporaryFDAOngoing
Can cause harm that is usually temporary.
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
Check the device or its packaging for
1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;
- Why
- An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Distributed
- US Nationwide distribution.
- Company
- Atrium Medical Corporation
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3113-2026 · retrieved 4 September 2026
Read the official notice