AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5
Summary
The FDA issued a Class II for AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size by SunMed Holdings, LLC. Reason: There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pa.
Details
Source
Device Recall
External ID
Z-1020-2023
Action Date
2023-02-01
Status
Ongoing
Category
device
Product Description
AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 60305 4.0 60405
Lot/Code Info: ALL LOTS Size REF UDI/DI 0.0 60005 Each: 00814954020263 Box: 10814954020260 Case: 20814954020267 0.5 60055 Each: 00814954020270 Box: 10814954020277 Case: 20814954020274 1.0 60105 Each: 00814954020287 Box: 10814954021083 Case: 20814954020281 1.5 60155 Each: 00814954020294 Box: 10814954021090 Case: 20814954020298 2.0 60205 Each: 00814954020300 Box: 10814954021106 Case: 20814954020304 3.0 60305 Each: 00814954020317 Box: 10814954021113 Case: 20814954020311 4.0 60405 Each: 00814954020324 Box: 10814954021120 Case: 20814954020328
Quantity Affected: 43,290 (Eaches)
Reason for Recall
There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.
Distribution
US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-22
Company
Grand Rapids, MI
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 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SunMed Holdings, LLC has 18 FDA actions in our database, including 18 recalls.
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 (SunMed Holdings, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SunMed Holdings, LLC have FDA actions?
SunMed Holdings, LLC has 18 FDA actions in our database, including 18 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1020-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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