# FDA recall Z-0753-2021

> **Intersurgical Inc** · Class II · device recall initiated 2020-11-11.

## Product

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

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

## Key facts

- **Recall number:** Z-0753-2021
- **Recalling firm:** Intersurgical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-11
- **Report date:** 2021-01-06
- **Termination date:** 2022-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Syracuse, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0753-2021

## Citation

> AI Analytics. FDA recall Z-0753-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0753-2021. Source: US FDA. Licensed CC0.

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