# FDA recall Z-2795-2020

> **Bioseal Corporation** · Class II · device recall initiated 2019-08-15.

## Product

Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

## Reason for recall

The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient. These cracks could possibly leak if they reach a significant size and pose a serious heath risk to patient.

## Distribution

US Nationwide distribution including in the state of CA.

## Key facts

- **Recall number:** Z-2795-2020
- **Recalling firm:** Bioseal Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-15
- **Report date:** 2020-08-19
- **Termination date:** 2021-03-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Placentia, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2795-2020

## Citation

> AI Analytics. FDA recall Z-2795-2020. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-2795-2020. Source: US FDA. Licensed CC0.

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