Summary
The FDA issued a Class II for GEM FLOW COUPLER Monitor, PN 5156-00000-011 by Baxter Healthcare Corporation. Reason: An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on usin.
Details
Source
Device Recall
External ID
Z-2208-2023
Action Date
2023-07-26
Status
Ongoing
Category
device
Product Description
GEM FLOW COUPLER Monitor, PN 5156-00000-011
Lot/Code Info: GTIN 00844735006148, all serial numbers
Quantity Affected: 122 units
Reason for Recall
An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.
Distribution
US
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-19
Company
Deerfield, IL
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 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 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 (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2208-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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