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VentStar Basic (P)180, MP00351 recallZ-1440-2023 · Draeger Medical, Inc. · initiated Apr 17, 2023

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Draeger Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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].

Recall details

Recall number
Z-1440-2023
Status
Terminated
Initiated by the company
Apr 17, 2023
Posted by the FDA
May 17, 2023
Recalling firm
Draeger Medical, Inc.
Quantity
325 units
Product code
CAI
Distribution
Domestic: US Nationwide Distribution.

Product description

VentStar Basic (P)180, MP00351

Code information (models, lots, serial numbers)

UDI-DI: 04048675422068; All lots.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 92049).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page