Exact FDA event identifier

Event 76945

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: April 03, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Intersurgical Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0208-2018

Recall number: Z-0208-2018
Initiated: April 03, 2017
Classification: Class II
Status: Terminated
Recalling firm: Intersurgical Inc
Quantity: 144 cases / 20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.

Code information

Product Lots: 31402822 to 31610791

Distribution pattern

Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico