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U.S. Department of Health and Human Services

Class 1 Device Recall Carina SubAcute Care Ventilator

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 Class 1 Device Recall Carina SubAcute Care Ventilatorsee related information
Date Initiated by FirmJuly 12, 2023
Date PostedAugust 18, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2248-2023
Recall Event ID 92629
510(K)NumberK072885 
Product Classification Ventilator, continuous, facility use - Product Code CBK
ProductCarina Sub-Acute Care Ventilator
Code Information Part No. 5704110; UDI-DI 04048675398516; All Serial No.
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information ContactMike Kelhart
267-664-1131
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe 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.
Quantity in Commerce11,621 units
DistributionUS Nationwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CBK
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