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

Recall date

March 7, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1727-2019

FDA classification

Class II

Brand / firm

Stryker Corporation

Sold / distributed

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 Urug…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.