Reported Jul 13, 2022 · Ongoing
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis,…
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 HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Lot codes and dates
452 of 452 codes
Code Information organized as "Model NoSerial NoGTIN": 8888119369P2031800118108845211577368888119369P1914400127208845211577338888119369P1914400128208845211577338888119369P1933700096208845211577338888119369P1934400105208845211577338888119369P2001400076208845211577338888119369P2005600026208845211577338888119369P2012100180208845211577338888119369P2012100187208845211577338888119369P2017500127208845211577338888119369P2021000082208845211577338888119369P2026000164208845211577338888119369P2028200156208845211577338888119369P2028200165208845211577338888119369P2028200185208845211577338888119369P2028200226208845211577338888119369P2031800118208845211577338888119369P2104600161208845211577338888119369P2104600257208845211577338888119369P
- Amount recalled
- 25,765 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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