Covidien recalls certain Palindrome HSI Chronic Catheters due to a potential leak in the hub that could cause unanticipated fluid return during use. Affected units have specific model and serial numbers.
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.
Covidien is recalling specific models of Palindrome HSI Chronic Catheters because they may leak fluid during use due to a design flaw in the hub. This could lead to unexpected fluid return, which might cause complications for patients needing dialysis.
The catheter hub has an inter-lumen void that can cause fluid to leak unexpectedly during use. This may result in unanticipated fluid return, which could lead to complications for patients receiving dialysis treatments.
Patients using hemodialysis or apheresis treatments with the recalled catheters are most at risk. Healthcare providers who use these catheters for chronic dialysis treatments may also be affected.
Check the model number and serial number on the catheter packaging. The affected units have specific model numbers (8888119369, 8888123409, 8888145048, 8888145049, 8888145050, 8888145057, 8888145048C, 8888145049C, 8888145050C, 8888145057C) and corresponding serial numbers listed in the recall notice.
Look for the model number and serial number on the packaging to determine if it is affected.
If you have the recalled catheter, contact your healthcare provider for instructions on next steps.
The catheter hub has a potential inter-lumen void that may cause unanticipated fluid return during use, which could lead to complications for patients needing dialysis.
Affected model numbers include 8888119369, 8888123409, 8888145048, 8888145049, 8888145050, 8888145057, and variants with suffixes like C (e.g., 8888145048C).
The recall does not require immediate discontinuation; however, if you have the affected model, contact your healthcare provider for guidance.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1319-2022 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1319-2022 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
