Reported Jul 13, 2022 · Ongoing
Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis,…
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 Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Lot codes and dates
2,443 of 2,443 codes
Code Information organized as "Model NoSerial NoGTIN": 88881193601916500132208845210128038888119364183100009920884521056555888811936418323001142088452105655588881193642019500276208845210565558888119364210690022620884521056555888812340419126001082088452105658688881234041934400172208845210565868888123404201210013620884521056586888812340420175001302088452105658688881234042034400075208845210565868888123404210460023620884521056586888812340421258000942088452105658688881234042127200415208845210565868888123410201950025320884521012988888812341021041000792088452101298888881284502127200431208845210130088888128454201780006110884521056619888812845418226001212088452105661688881284542017800061208845210566168888128460
- Amount recalled
- 576,018 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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