Covidien recalls specific Palindrome SI Chronic Catheters for possible fluid leaks during dialysis use. Affected units have model numbers starting with 8888119368 or 8888145062-66. Stop using if you have these catheters.
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 certain Palindrome SI Chronic Catheters used in dialysis treatments due to a potential leak in the hub component. This leak could cause unanticipated fluid return during use, which may lead to complications for patients.
The catheter hub has a small gap (inter-lumen void) that can allow fluid to leak unexpectedly during use. This could cause unanticipated fluid return, potentially leading to complications like infection or fluid imbalance in patients.
Patients using hemodialysis or apheresis treatments with the recalled catheters are most at risk. Healthcare providers who administer these catheters should also check their inventory.
Check for model numbers starting with 8888119368 or 8888145062-66 on the catheter packaging or label. The catheter is sterile, single-use, and requires a prescription for medical use.
Look for model numbers starting with 8888119368 or 8888145062-66 on the catheter packaging or label.
If you have the recalled model, stop using the catheter and contact your healthcare provider for alternative options.
The catheter hub has a potential leak due to an inter-lumen void, which could cause unanticipated fluid return during use.
Model numbers starting with 8888119368 or 8888145062-66 are affected.
The recall does not specify a return process, but you should stop using it and contact your healthcare provider for alternatives.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1318-2022 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1318-2022 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.
