Reported Jun 12, 2019 · Terminated
Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx,…
Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Corporation · 5900 Optical Ct · San Jose, CA · 95138-1400
Is this the product you have?
- Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
- Lot codes and dates
- UDI - 07613327055634 Lot numbers
235 of 235 codes
18G026918H035318K0379560043205600432556004329560043565600436656004373560043845600438756004426560044325600444156004443560044515600445956004461560044875600449456004502560045085600451556004518560045285600455156004565560045735600458456004600560046145600461656004624560046285600463256004681560046865600469656004704560047195600472156004735560047375600473956004748560047505600476056004771560047915600479556004809560048115600481656004818560048205600482256004826560048305600484256004844
- UDI - 07613327055634 Lot numbers
- Amount recalled
- 32,537 boxes
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The heated tube sets were consistently leaking and detaching from the cassette.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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