Stryker Corporation recalls Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High

Recalled June 12, 2019 · FDA recall Z-1727-2019 · Stryker

Hazard

The heated tube sets were consistently leaking and detaching from the cassette. · FDA Class II

Units

5,089 boxes

Sold at

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.

Description

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

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.

Manufacturer(s)

Stryker Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →