FDA recall Z-1494-2025

Draeger, Inc. · Class I · device

Product

Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult Component: Not applicable

Reason for recall

The potential for cracks forming in the breathing circuit hose.

Distribution

Domestic: Nationwide Distribution. International - following countries: Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, United Kingdom

Key facts

Status: Ongoing
Initiation date: 2025-03-12
Report date: 2025-04-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1494-2025