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U.S. Department of Health and Human Services

Class 1 Device Recall Ventstar Coax

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  Class 1 Device Recall Ventstar Coax see related information
Date Initiated by Firm April 17, 2023
Date Posted May 17, 2023
Recall Status1 Open3, Classified
Recall Number Z-1457-2023
Recall Event ID 92049
Product Classification Set, tubing and support, ventilator (w harness) - Product Code BZO
Product Ventstar Coax 230, MP03376
Code Information UDI-DI: 04048675545613; All lots.
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Michael Kelhart
215-660-2349
Manufacturer Reason
for Recall		 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
FDA Determined
Cause 2		 Process control
Action The firm distributed recall notifications to consignees via FedEx starting on 4/17/2023. Consignees are instructed to immediately stop use of affected devices, inspect current stock, and quarantine any affected devices to prevent use. Alternative therapy for patients should be instituted as soon as possible and ensure all users of affected devices within consignee organizations are aware of the recall, with copies being forwarded if devices were further distributed. To replace or return unused products, consignees are to call Draeger Customer Success between 8:00 AM - 6:00 PM EST, Monday thru Friday, at 1-800-437-2437 (option 2, then option 1), or via email at US-Medical@draeger.com. A Return Materials Authorization and pre-paid shipping label will be provided upon request. Any additional questions regarding the recall communication may be directed to Mr. Michael Kelhart between the hours of 8:00 AM - 4:30 PM by phone at 267-664-1131 or by email at mike.kelhart@draeger.com.
Quantity in Commerce 40 units
Distribution Domestic: US Nationwide Distribution.
Total Product Life Cycle TPLC 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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