Reported Jul 13, 2022 · Ongoing
Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic…
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 Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access 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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