Summary
The FDA issued a Class I for Carina Sub-Acute Care Ventilator by Draeger Medical, Inc.. Reason: Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30.
Details
Source
Device Recall
External ID
Z-2248-2023
Action Date
2023-08-30
Status
Ongoing
Category
device
Product Description
Carina Sub-Acute Care Ventilator
Lot/Code Info: Part No. 5704110; UDI-DI 04048675398516; All Serial No.
Quantity Affected: 11,621 units
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.
Distribution
US Nationwide Distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-12
Company
Telford, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Draeger Medical, Inc. has 37 FDA actions in our database, including 37 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Draeger Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Draeger Medical, Inc. have FDA actions?
Draeger Medical, Inc. has 37 FDA actions in our database, including 37 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2248-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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