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U.S. Department of Health and Human Services

Class 1 Device Recall Anesthesia Circuit Kit

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 Class 1 Device Recall Anesthesia Circuit Kitsee related information
Date Initiated by FirmMarch 12, 2025
Date PostedApril 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1495-2025
Recall Event ID 96342
Product Classification Anesthesia breathing circuit kit (adult & pediatric) - Product Code OFP
ProductBrand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable
Code Information Model/Catalog Number: MP02737; UDI Number 04048675389620; All lot numbers.
Recalling Firm/
Manufacturer		 Draeger, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information ContactMichael Kelhart
01-267-6641131
Manufacturer Reason
for Recall		 The potential for cracks forming in the breathing circuit hose.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 mike.kelhart@draeger.com. The US Food and Drug Administration has been advised of this action.
Quantity in Commerce3140
DistributionDomestic: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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