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.
FDA Recall Z-1727-2019 · Posted None
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Recalling FirmStryker Corporation
Recall StatusTerminated
Product CodeHIF
Date Initiated2019-03-07
Date Terminated2024-03-08
Product Quantity5,089 boxes
Reason for Recall
The heated tube sets were consistently leaking and detaching from the cassette.
Firm Action
The recalling firm issued letters dated 3/7/2019 via certified mail on 3/7/2019. A second letter dated 3/7/2019 was issued on 4/15/2019 via certified mail to two customers which included an additional lot number for one of the products.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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