SunMed Holdings, LLC Recall 91391
Description: 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
SunMed Holdings, LLC Recall 91391 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1019-2023 |
| Event ID | 91391 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA. |
| Quantity | 43,290 (Eaches) |
| Recall 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 pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter. |
| Device Classification | 20230201 |
| Device Code Info | ALL LOTS Size REF UDI/DI 0.0 50005 Each: 00814954020188 Box: 10814954020185 Case: 20814954020182 0.5 50055 Each: 00814954020195 Box: 10814954020192 Case: 20814954020199 1.0 50105 Each: 00814954020201 Box: 10814954021007 Case: 20814954020205 1.5 50155 Each: 00814954020218 Box: 10814954021014 Case: 20814954020212 2.0 50205 Each: 00814954020225 Box: 10814954021021 Case: 20814954020229 3.0 50305 Each: 00814954020232 Box: 10814954021038 Case: 20814954020236 4.0 50405 Each: 00814954020249 Box: 10814954021045 Case: 20814954020243 |
| Center Classification Date | 20230126 |
| Recall Initiation Date | 20221222 |
| Recalling Firm | SunMed Holdings, LLC |
| Initial Notification | Letter |
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