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U.S. Department of Health and Human Services

Class 2 Device Recall AirQ3

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  Class 2 Device Recall AirQ3 see related information
Date Initiated by Firm December 22, 2022
Date Posted January 26, 2023
Recall Status1 Open3, Classified
Recall Number Z-1019-2023
Recall Event ID 91391
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
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
Code Information 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
Recalling Firm/
Manufacturer		 SunMed Holdings, LLC
2710 Northridge Dr Nw Ste A
Grand Rapids MI 49544-9112
For Additional Information Contact Rob Yamashita
616-259-8400
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action On December 22, 2022, the firm notified affected customers through Urgent Medical Device Product Correction letters. Customers were informed that there is a discrepancy in the orogastric (OG) tube size indicated in the labeling in the instructions for use (IFU) versus the printed text on the device. Customers were provided with the correct recommended maximum OG tube/catheter sizes for each impacted Air-Q3G and Air-Q SPG model. If product has been further distributed, customers should forward the recall notice. If customers have questions about this recall notification, please contact Rob Yamashita, VP of Regulatory Affairs, at 616-259-8400, toll free at 800-433-2729, or ryamashita@sun-med.com.
Quantity in Commerce 43,290 (Eaches)
Distribution US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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