Z-1493-2025Class I

Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not...

Name: Z-1493-2025 Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not...
Creator: Draeger, Inc.
Published: 2025-03-12
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2025-03-12 / Open, Classified

FDA source

Draeger, Inc. began a recall of Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for... on 2025-03-12. FDA classified it as Class I and gives the reason as "The potential for cracks forming in the breathing circuit hose". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1493-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-03-12
Posted: 2025-04-03
Recalling firm: Draeger, Inc.
Product: Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is intended for single use only. Component: Not applicable
Product code: CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Reason for recall: The potential for cracks forming in the breathing circuit hose.
FDA root cause: Under Investigation by firm
Action: On March 12, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be Taken When using these breathing circuits: 1. Use holders with a larger contact surface (see Figure 2 above). 2. Perform leak testing after stretching the flexible hose to the required length for the application. Please observe the products Instructions for Use (IFU) According to our records, you have received at least one of the listed breathing circuits. Please inform all potential users in your facility. If you have forwarded affected products to third parties, please also forward this Urgent Medical Device Recall notification. Please also complete the enclosed Medical Device Recall Return Response Acknowledgment and Receipt Form to confirm to us that you have received this information. Adverse events or quality problems experienced with the use of this product may be reported to FDA s MedWatch Adverse Event Reporting program either online or by phone at 1-800-FDA-1088. We apologize for any inconveniences resulting from this action. If you have any questions regarding this letter, please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 267-664-1131 or via email at [email protected]. The US Food and Drug Administration has been advised of this action. ****Update 07/08/2025****On June 25, 2025 URGENT MEDICAL DEVICE RECALL - UPDATE letters were sent to consignees to clarify and provide complete UDI information for the device to include both primary and secondary UDI numbers as errors were identified in the initial letter.
Quantity in commerce: 65150 units
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
Product codes and lots: Model/Catalog Number: MP00355; UDI Number 04048675248996; All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1493-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1493-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-04-03
Z-1494-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-04-03
Z-1495-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-04-03
Z-1496-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-04-03
Z-1497-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-04-03
Z-1498-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-04-03
Z-1499-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-04-03

Product code CAI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)