Intersurgical Inc: Medical Device Recall in 2021 - (Recall #: Z-0753-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 11, 2020

Date Posted: January 6, 2021

Recall Number: Z-0753-2021

Event ID: 86800

Reason for Recall:

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

Status: Terminated

Product Quantity: 200 devices

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated