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Carina Sub-Acute Care Ventilator recallZ-2248-2023 · Draeger Medical, Inc. · initiated Jul 12, 2023

Class I Open, Classified All recalls posted in August 2023

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

Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.

FDA root cause category: Nonconforming Material/Component

What the company is doing

The firm, Drager, sent an "Urgent Medical Device Recall" to customers by mail on 07/12/2023. The medical device recall notification instructs customers on how to utilize the Carina Ventilator until units can be corrected in the field by way of replacement of the blower to remove the presence of PE-PUR foam. Customers may continue to use the device until it has been modified provided that the set minute volume exceeds 3.6 l/min, only adult patients are ventilated, and only a Draeger ventilation hose with leak valve is used. The firm states that a new designed blower cover will be available in the early part of the fourth quarter of 2023 and Draeger will facilitate field service free of charge. Customers are to ensure all users and maintenance staff that utilize the recalled device are made aware of the recall notice. Customers with any questions regarding the operation of the Carina Ventilator are to contact Technical Support between 8:00 AM and 8:00 PM EST at 1-800-437-2437 (press 2, then 2, then 2); customers with any questions about the recall notice are to contact Michael Kelhart from 8:00 AM to 4:30 PM EST at 267-664-1131 or by email at [email protected]. The Medical Device Recall Response form is to be returned by fax 215-372-2940 or email: [email protected] to Draeger upon completion.

Recall details

Recall number
Z-2248-2023
Recall class
Class I (most serious)
Status
Open, Classified
Initiated by the company
Jul 12, 2023
Posted by the FDA
Aug 18, 2023
Recalling firm
Draeger Medical, Inc.
Quantity
11,621 units
Product code
CBK
FDA submissions
K072885
Distribution
US Nationwide Distribution.

Product description

Carina Sub-Acute Care Ventilator

Code information (models, lots, serial numbers)

Part No. 5704110; UDI-DI 04048675398516; All Serial No.

Devices named in this recall

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

Sources and updates

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