Class II

Medical Device Recall: Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);

Atrium Medical Corporation · August 7, 2026

Reason for Recall

An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

256

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3113-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.