Reported Jul 13, 2022 · Ongoing
Palindrome SI 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 SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Lot codes and dates
65 of 65 codes
Code Information organized as "Model NoSerial NoGTIN": 88881193681925200090208845210128418888119368193370009420884521012841888811936820014000772088452101284188881193682026000056208845210128418888123408200940011420884521012957888812845819351000682088452101303988881335082026000060208845210131078888145062203180015310884521013407888814506219337000952088452101340488881450622009400116208845210134048888145062203180013120884521013404888814506220318001532088452101340488881450632000700056208845210134288888145063200940011320884521013428888814506320272001812088452101342888881450642030100077208845210134428888145065202600006720884521013466888814506620119001041088452101347688881450662019500162108845210134768888145066
- Amount recalled
- 2,462 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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