Reported Jun 12, 2019 · Terminated
Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High…
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 Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
- Lot codes and dates
- UDI - 07613327055658
- Lot numbers
192 of 192 codes
560043335600433556004337560043425600435256004375560043935600441956004421560044235600443556004445560044475600446556004481560044855600451256004520560045345600454156004575560045775600458656004597560046025600462656004630560046435600464556004649560046515600471056004723560047255600474156004752560047545600475756004782560047865600479356004836560048385600484056004850560048635600488456005075560050775600508156005083560050855600508756005089560050915600509356005110560051125600511456005116
- Amount recalled
- 19,083 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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