Reported Jul 13, 2022 · Ongoing
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and…
Covidien LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Covidien Llc · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
- Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Lot codes and dates
281 of 281 codes
Code Information organized as "Model NoSerial NoGTIN": 88881193692009300138108845210128758888119369193510007020884521012872888811936920093001382088452101287288881193692026000146208845210128728888119369202820016020884521012872888812340920007000621088452101296788881234092000700062208845210129648888123409200140008120884521012964888812340920094001122088452101296488881284592127200434108845210130498888128459212720043420884521013046888813350920260001472088452101311488881450482005600027108845210132788888145048200940010610884521013278888814504820121001821088452101327888881450482012100188108845210132788888145048201490014110884521013278888814504820282001611088452101327888881450482028200170108845210132788888145048
- Amount recalled
- 13,526 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
Stop using this product now
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
Using this product could cause serious injury, illness or death — stop using it now.
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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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