Reported Jun 12, 2019 · Terminated
Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE…
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 Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
- Lot codes and dates
- UDI - 07613327055641
- Lot numbers
18G027318H032318H035456004327560043915600443456004478560045265600459256004665560046675600470656004708560047845600483256005325560053765600537856005380560054115600545056005459560055385600554056005633560056355600574456005790560058995600590156005989560059975600599956006142560061545600627056006340560064345600652156006527560065565600656056006606
- Amount recalled
- 5,089 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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