Reported Jul 13, 2022 · Ongoing
Palindrome Precision 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 Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Lot codes and dates
2,384 of 2,384 codes
Code Information organized as "Model NoSerial NoGTIN": 88881234001729700111208845210129338888123400183100013020884521012933888812340019046000852088452101293388881335002012100128208845210130608888119360P2007800129108845211576998888119360P2034400078108845211576998888119360P1720000102208845211576968888119360P1904200103208845211576968888119360P1923400228208845211576968888119360P1932300203208845211576968888119360P2007800129208845211576968888119360P2034400078208845211576968888119360P2104600179208845211576968888119360P2110900110208845211576968888119360P2113300438208845211576968888119360P2127700068208845211576968888119364P1925200093108845211577058888119364P1934400186108845211577058888119364P2019500171108845211577058888119364P
- Amount recalled
- 213,589 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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