FDA recall Z-3113-2026

Atrium Medical Corporation · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2026-08-07
Report date
2026-09-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Merrimack, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3113-2026