# FDA recall Z-1727-2019

> **Stryker Corporation** · Class II · device recall initiated 2019-03-07.

## Product

Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.

## Reason for recall

The heated tube sets were consistently leaking and detaching from the cassette.

## Distribution

Distribution was nationwide to medical facilities.  There was government/military distribution.   Foreign distribution was made to Argentina, Brazil, Canada, Chile, Colombia, (EMEA-no specific address/country listed), India, Japan, Latin America (no country listed), Mexico, Saudi Arabia, UAE, and Uruguay.

## Key facts

- **Recall number:** Z-1727-2019
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-07
- **Report date:** 2019-06-12
- **Termination date:** 2024-03-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1727-2019

## Citation

> AI Analytics. FDA recall Z-1727-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1727-2019. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
