Reported Jul 13, 2022 · Ongoing
Palindrome Precision H 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 H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Lot codes and dates
494 of 494 codes
Code Information organized as "Model NoSerial NoGTIN": 8888119365P2119400168108845211577128888119365P1923400245208845211577198888119365P1923400268208845211577198888119365P1935100114208845211577198888119365P2002100145208845211577198888119365P2002900148208845211577198888119365P2020400090208845211577198888119365P2023300173208845211577198888119365P2026000162208845211577198888119365P2031800126208845211577198888119365P2034400186208845211577198888119365P2104600103208845211577198888119365P2104600233208845211577198888119365P2108100057208845211577198888119365P2116500094208845211577198888119365P2116500095208845211577198888119365P2119400168208845211577198888119371P1935100115108845211577508888123405P2002100146108845211577818888123405P
- Amount recalled
- 26,675 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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