Z-0208-2018Class II

Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2...

Name: Z-0208-2018 Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2...
Creator: Intersurgical Inc
Published: 2017-04-03
License: https://open.fda.gov/license/

Intersurgical Ltd. / initiated 2017-04-03 / Terminated / root cause: manufacturing process

FDA source

Intersurgical Inc began a recall of Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5... on 2017-04-03. FDA classified it as Class II and gives the reason as "A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0208-2018
Classification: Class II
Status: Terminated
Initiated: 2017-04-03
Posted: 2017-12-07
Terminated: 2019-06-17
Recalling firm: Intersurgical Ltd.
Product: Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 Patent airway management.
Product code: BYG Mask, Oxygen
Reason for recall: A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Intersurgical sent an Urgent Medical Device Recall Notice dated April 3rd, 2017, along with response forms to Customers. Customers were advised to immediately discontinue use and quarantine affected products. If affected products were further distributed, customers are advised to notify those individuals and advise them of the recall situation and have them return their outstanding stock to you. Customers with questions can call the IS Customer Service line at 800-828-9633 for a Return Authorization Number. Once customers receive the Return Authorization Number, please enter it in the space provided on the Recall Response Form. The completed Recall Response Form should be emailed to: [email protected] For further questions, please call (315) 451-2900)
Quantity in commerce: 144 cases / 20 units
Distribution: Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico
Product codes and lots: Product Lots: 31402822 to 31610791

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0208-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0208-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-07

Product code BYG

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)