Z-0096-2023Class II

Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000

Name: Z-0096-2023 Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Creator: Intersurgical Inc
Published: 2022-08-29
License: https://open.fda.gov/license/

Intersurgical Ltd. / initiated 2022-08-29 / Terminated

FDA source

Intersurgical Inc began a recall of Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000 on 2022-08-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0096-2023
Classification: Class II
Status: Terminated
Initiated: 2022-08-29
Posted: 2022-10-17
Terminated: 2023-10-19
Recalling firm: Intersurgical Ltd.
Product: Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Product code: CAE Airway, Oropharyngeal, Anesthesiology
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 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 [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].
Quantity in commerce: 340 pieces
Distribution: OH, TN, TX
Product codes and lots: UDI-DISingle unit: 5030267073511 UDI-DICase: 05030267046959 Lot code: 32204071

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0096-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0096-2023	Class II	Terminated	Voluntary: Firm initiated	2022-10-26	2022-10-17

Product code CAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)