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U.S. Department of Health and Human Services

Class 2 Device Recall Intersurgical Laryngeal Mask

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  Class 2 Device Recall Intersurgical Laryngeal Mask see related information
Date Initiated by Firm August 29, 2022
Date Posted October 17, 2022
Recall Status1 Terminated 3 on October 19, 2023
Recall Number Z-0096-2023
Recall Event ID 90855
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
Product Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg

Model Number: 8003000
Code Information UDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071
Recalling Firm/
Manufacturer		 Intersurgical Inc
6757 Kinne St
East Syracuse NY 13057-1215
For Additional Information Contact SAME
315-451-2900
Manufacturer Reason
for Recall		 Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot balloon) may pose health risk to the patient
FDA Determined
Cause 2		 Under Investigation by firm
Action Intersurgical Inc. issued Urgent Medical Device Recall Letter via email on 08/29/2022 and via certified first-class mail to Distributors. Letter states reason for recall, health risk and action to take: The recall extended to the user level. Recall Instructions: i. Immediately discontinue use and quarantined any stock with the product/lot number described above in this recall notification. ii. If you have distributed any of these products, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you. iii. Contact Intersurgical Customer Support at 800-828-9633 for a Return Goods Authorization (RGA) Number. Hours of operation are Monday through Friday, 8:00 a.m. to 4:30 p.m. EST. i. Once you have received the RGA Number, please enter it in the space provided on the Customer Product Recall Acknowledgement Form: ii. Return the completed form via email to Intersurgical Inc. at support@intersurgicalinc.com. iii. The subject line should contain your Company name and RGA number. 1. This will allow us to document your receipt of this letter and the amount of product you have on-hand for return. iv. Intersurgical will credit your account when the product is received. v. Please note: If you do not have the recalled product in stock, please check the appropriate box on the Customer Product Recall Acknowledgement Form. vi. Return the completed form via email to Intersurgical Inc. at support@intersurgicalinc.com. vii. The subject line should contain your Company name and Intersurgical Recall. Contact :315-451-2900 ext. 500 or email: kcambpell@intersurgicalinc.com.
Quantity in Commerce 340 pieces
Distribution OH, TN, TX
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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