FDA Medical Device Recalls (openFDA)
Intersurgical Inc: Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
- Recall number
- Z-0096-2023
- Recalling firm
- Intersurgical Inc
- Product
- Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
- Status
- Terminated
- Initiated
- 2022-08-29
- Posted
- 2022-10-17
- Terminated
- 2023-10-19
- Reason
- 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
- Root cause
- 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
- 340 pieces
- Distribution
- OH, TN, TX
- Lot, serial or model codes
- UDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAE
- Firm FEI
- 1000120301
- Firm city
- East Syracuse
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28