Home / Recalls / Intersurgical Inc / Z-0753-2021

Z-0753-2021 Class II Terminated

Recalled by Intersurgical Inc — East Syracuse, NY

Recall Details

Product Type
Devices
Report Date
January 6, 2021
Initiation Date
November 11, 2020
Termination Date
August 9, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
200 devices

Product Description

Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

Reason for Recall

The device was assembled with the incorrect exhalation port which can cause gas leakage.

Distribution Pattern

All of the devices were shipped to the same distributor (McKesson).

Code Information

Model Number: B0062001 Lot Numbers: 4200283 and 4200286 UDI Codes: (01)00081647202239(10)4200286 (01)00081647202239(10)4200283

Other recalls by Intersurgical Inc

  • Z-2275-2025 Class II — One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. (June 20, 2025)
  • Z-2276-2025 Class II — One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. (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-0787-2020 Class II — Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port (August 7, 2019)
  • 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-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)
  • Z-0208-2018 Class II — Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: (April 3, 2017)