Home / Recalls / Intersurgical Inc / Z-0208-2018

Z-0208-2018 Class II Terminated

Recalled by Intersurgical Inc — E. Syracuse, NY

Recall Details

Product Type
Devices
Report Date
December 13, 2017
Initiation Date
April 3, 2017
Termination Date
June 17, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
144 cases / 20 units

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

Product Lots: 31402822 to 31610791

Other recalls by Intersurgical Inc

  • Z-2276-2025 Class II — One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. (June 20, 2025)
  • Z-2275-2025 Class II — One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. (June 20, 2025)
  • Z-2102-2025 Class I — i-view video laryngoscope. Model Number: 8008000. The i-view video laryngosc (June 17, 2025)
  • Z-0096-2023 Class II — Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50k (August 29, 2022)
  • Z-0753-2021 Class II — Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Cu (November 11, 2020)
  • Z-0785-2020 Class II — Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030 (August 7, 2019)
  • Z-0784-2020 Class II — Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000 (August 7, 2019)
  • Z-0787-2020 Class II — Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port (August 7, 2019)
  • Z-0786-2020 Class II — Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port (August 7, 2019)
  • Z-2302-2018 Class II — Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 800 (April 25, 2018)