Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
Summary
The FDA issued a Class II for Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. n by Draeger Medical Systems, Inc.. Reason: The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rate.
Details
Source
Device Recall
External ID
Z-1365-2022
Action Date
2022-07-20
Status
Ongoing
Category
device
Product Description
Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
Lot/Code Info: Model, country, and serial number: MS20508: El Salvador DSPN-0003 Mexico DSPM-0003, DSPH-0002 Chile DSPL-0003 Saudi Arabia DSPJ-0003, DSPL-0004, DSPL-0005, DSPL-0006, DSPL-0007, DSPM-0001, DSPM-0002, DSPL-0008, DSPK-0002, DSPH-0003, DSPJ-0004, DSRA-0001 Kuwait DSPJ-0002, DSPK-0001 India DSPN-0001, DSPN-0002, DSRA-0002 Taiwan DSPL-0001, SPL-0002, DSPJ-0001 MS20509: Germany DSPH-0003 Qatar DSPL-0007, DSRB-0001 Spain DSPK-0002, DSPJ-0006, DSPJ-0003, DSPH-0001, DSPJ-0004, DSPK-0001, DSPL-0008 Hungary DSPF-0003 Belarus DSPJ-0005 United Kingdom DSPF-0002 Italy DSPJ-0002
Quantity Affected: 38 OUS (no US distribution)
Reason for Recall
The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.
Distribution
No US distribution. Foreign distribution to BY, CL, DE, ES, GB, HU, IN, IT, KW, MX, SA, SV, TW.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-20
Company
Telford, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Draeger Medical Systems, Inc. has 14 FDA actions in our database, including 6 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 Systems, 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 Systems, Inc. have FDA actions?
Draeger Medical Systems, Inc. has 14 FDA actions in our database, including 6 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1365-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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