FDAMarch 7, 2019device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The heated tube sets were consistently leaking and detaching from the cassette.
What to do
FDA enforcement status: Terminated
Brands named
stryker
UPCs
07613327055641
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Tip Steerable, Product Number 6DYNTP001;2026-04-10
- FDABARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDADaig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
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