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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-1020-2023
Recall Event ID 91391
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
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
Code Information ALL LOTS Size REF UDI/DI 0.0 60005 Each: 00814954020263 Box: 10814954020260 Case: 20814954020267 0.5 60055 Each: 00814954020270 Box: 10814954020277 Case: 20814954020274 1.0 60105 Each: 00814954020287 Box: 10814954021083 Case: 20814954020281 1.5 60155 Each: 00814954020294 Box: 10814954021090 Case: 20814954020298 2.0 60205 Each: 00814954020300 Box: 10814954021106 Case: 20814954020304 3.0 60305 Each: 00814954020317 Box: 10814954021113 Case: 20814954020311 4.0 60405 Each: 00814954020324 Box: 10814954021120 Case: 20814954020328
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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