Reported Jul 20, 2022 · Completed
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Cook Incorporated
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: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
- Lot codes and dates
- UDI-DI(01)00827002028388
- Lot Numbers
153 of 153 codes
966571696799429686540968654996892509689343969254896925499699716969971797057389709183971215097123739736455974251097465759746716976040497604759766121977511997803269782923978543397924679793490979963297996389804929982401998268289826829982965498305249836105983620998717349873996988939198923719895593989813298987309902290990292799104859916495991650399241219931357993154199381869938235994624199526269952627995272699540449954213
- Amount recalled
- 11,451 units
Where it was sold
- Nationwide
Why it was recalled
The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia.
This product could cause temporary or reversible health problems — stop using it.
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