ID Circuit Basic (P) 180, MP01340
FDA Recall Z-1446-2023 · Posted 2023-05-17
Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeBZO
Date Initiated2023-04-17
Date Terminated2024-09-03
Product Quantity25 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.