Recall record at a glance
| Official record | Z-1020-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | SunMed Holdings, LLC |
| Report date | Feb 1, 2023 |
| Recall initiation date | Dec 22, 2022 |
| Quantity | 43,290 (Eaches) |
| Location | Grand Rapids, MI, United States |
Official 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
Why the product 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.
Distribution information
US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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