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Terminated

VentStar Coax (P) 150, MP00379

FDA Recall Z-1451-2023 · Posted 2023-05-17

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeBZO
Date Initiated2023-04-17
Date Terminated2024-09-03
Product Quantity280 units

Reason for Recall

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Firm 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 [email protected]. 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 [email protected].

Root Cause

Process control

Distribution Pattern

Domestic: US Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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