Carina Sub-Acute Care Ventilator

FDA device recall Z-2248-2023 · posted 2023-08-18 · Open, Classified

Recall details

Recalling firm

Draeger Medical, Inc.

Reason for recall

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.

Action taken

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 mike.kelhart@draeger.com. The Medical Device Recall Response form is to be returned by fax 215-372-2940 or email: ditelford.quality@draeger.com to Draeger upon completion.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

CBK

Quantity affected

11,621 units

Distribution

US Nationwide Distribution.

Date initiated

2023-07-12

Date posted

2023-08-18

Location

Telford, PA

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