The Recall Desk

FDA (Devices) recall action 91391

SunMed Holdings, LLC recalled 2 products on 2023-02-01

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2023-02-01
Critical
0
Units
86,580

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2023-02-01

    AirQ3 Intubating Laryngeal Airway Recall: Orogastric Tube Size Labeling Discrepancy

    SunMed is recalling 43,290 AirQ3 Self Pressurizing Intubating Laryngeal Airways due to a sizing discrepancy between device labeling and actual channel dimensions. Clinicians may need to use a smaller-diameter gastric catheter than indicated.

    Product
    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
    Category
    Distribution
    8 states
  • ModerateFDA (Devices)··2023-02-01

    Air-Q3 intubating laryngeal airway size labeling discrepancy between IFU and device

    SunMed's Air-Q3 intubating laryngeal airway devices have a discrepancy between the Instructions For Use and the printed text on the device regarding orogastric tube sizes, which could cause confusion when placing gastric catheters.

    Product
    Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405
    Category
    Distribution
    8 states