NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Summary
The FDA issued a Class I for NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP0158 by Draeger Medical, Inc.. Reason: The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic im.
Details
Source
Device Recall
External ID
Z-1138-2023
Action Date
2023-03-01
Status
Ongoing
Category
device
Product Description
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Lot/Code Info: All Lot numbers. UDI-DI: 04048675040552 (MP01579); 04048675040569 (MP01580); 04048675040538 (MP01581)
Quantity Affected: 893 units
Reason for Recall
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
Distribution
US Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-23
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 136 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-1138-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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