Reported Feb 1, 2023 · Ongoing
AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5…
SunMed Holdings, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SunMed Holdings, LLC · 2710 Northridge Dr Nw Ste A · Grand Rapids, MI · 49544-9112
Is this the product you have?
- AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number
0.0600050.5600551.0601051.5601552.0602053.0603054.060405
- Lot codes and dates
- ALL LOTS Size REF UDI/DI 0.0 60005
- Each00814954020263
- Box10814954020260
- Case20814954020267 0.5 60055
- Each00814954020270
- Box10814954020277
- Case20814954020274 1.0 60105
- Each00814954020287
- Box10814954021083
- Case20814954020281 1.5 60155
- Each00814954020294
- Box10814954021090
- Case20814954020298 2.0 60205
- Each00814954020300
- Box10814954021106
- Case20814954020304 3.0 60305
- Each00814954020317
- Box10814954021113
- Case20814954020311 4.0 60405
- Each00814954020324
- Box10814954021120
- Case20814954020328
- Amount recalled
- 43,290 (Eaches)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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