Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Smoothbore breathing system with exhalation port 22 mm Device REF Recalled by Intersurgical Inc Due to The device was assembled with the incorrect exhalation...

Date: November 11, 2020
Company: Intersurgical Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Intersurgical Inc directly.

Affected Products

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.

Quantity: 200 devices

Why Was This Recalled?

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

Where Was This Sold?

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

About Intersurgical Inc

Intersurgical Inc has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report