FDA (Devices) recall action 90311
The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Palindrome Precision Chronic Catheters used for dialysis may leak due to a flaw in the hub component, potentially allowing unintended fluid to escape during treatment.
Palindrome H Chronic Catheters are being recalled due to a potential leaking condition in the catheter hub that may result in unanticipated fluid return during hemodialysis treatment. Affected units have been distributed worldwide.
Covidien recalls 25,765 Palindrome Precision HSI Chronic Catheters due to a defect in the hub that may cause unintended fluid leakage during dialysis treatment.
Covidien is recalling 2,462 units of Palindrome SI Chronic Catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during treatment.
Covidien is recalling Mahurkar Chronic Carbothane dialysis catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during use. Approximately 132,443 units distributed worldwide are affected.
Covidien is recalling certain Palindrome Precision H Chronic Catheters because the hub may leak, causing unexpected fluid to flow back during use. This FDA Class I recall affects 26,675 units distributed globally.
Covidien recalls Palindrome Precision SI chronic dialysis catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during use.
Covidien is recalling Palindrome Chronic Catheters due to a potential leaking condition in the hub that may cause unexpected fluid return during use.
Covidien is recalling Palindrome HSI Chronic Catheters due to a potential leaking condition in the catheter hub that may cause unanticipated fluid return during dialysis. Approximately 13,526 units distributed worldwide are affected.