Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Recall
- Recall Number
- Z-0096-2023
- Event Number
- 90855
- Firm
- Intersurgical Inc
- FEI Number
- 1000120301
- Product Code
- CAE
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- August 29, 2022
- Posted
- October 17, 2022
- Terminated
- October 19, 2023
- Address
- 6757 Kinne St, East Syracuse, NY, 13057-1215
Description
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
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
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 [email protected]. 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 [email protected]. vii. The subject line should contain your Company name and Intersurgical Recall. Contact :315-451-2900 ext. 500 or email: [email protected].
OH, TN, TX
340 pieces