Reported Jul 13, 2022 · Ongoing
Palindrome H 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 H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Lot codes and dates
506 of 506 codes
Code Information organized as "Model NoSerial NoGTIN": 88881193651925200097208845210128108888119371203180011720884521056562888812340520282001682088452101294088881234052127200428208845210129408888145043193220008210884521013223888814504320037000421088452101322388881450432014900147108845210132238888145043202330016910884521013223888814504320318001131088452101322388881450432034400185108845210132238888145043210460010410884521013223888814504321081000541088452101322388881450432127200539108845210132238888145043191970011020884521013220888814504319295000762088452101322088881450431932200082208845210132208888145043200070010320884521013220888814504320037000422088452101322088881450432014900147208845210132208888145043
- Amount recalled
- 26,474 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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