FDA (Devices) recall action 88250
The FDA (Devices) publishes a recall like this one as 18 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 18 pages.
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
The agency’s own wording, quoted from the enforcement report.
Covidien voluntarily withdrew Palindrome RT Chronic Catheter Kit worldwide to implement improved point-of-use labeling and enhanced instructions for use on each device.
Covidien, LP is voluntarily withdrawing specific lots of the Palindrome RT Chronic Catheter Kit to implement point-of-use labeling and enhance the Instructions for Use.
Covidien, LP is voluntarily withdrawing Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and Instructions for Use. No injuries or illnesses have been reported.
Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to add point-of-use labeling and improve Instructions for Use. No adverse events have been reported.
Covidien, LP is voluntarily withdrawing Palindrome RT Repair Kit 15 FR to implement point-of-use labeling and enhance Instructions for Use.
Covidien is voluntarily withdrawing the Palindrome RT Chronic Catheter Kit to add point-of-use labeling and enhance instructions for use. The withdrawal affects specific lot numbers distributed worldwide.
Covidien, LP is voluntarily withdrawing the Palindrome RT Repair Kit to implement improved point-of-use labeling and enhance the Instructions for Use. This affects Item Code 8888541133 (Lot Number 1705400292) distributed worldwide.
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance device instructions for proper use.
Covidien is conducting a voluntary withdrawal of Palindrome RT Repair Kit 15 FR TAL 23cm devices to implement improved point-of-use labeling and enhance the Instructions for Use.
Covidien voluntarily withdrew Palindrome RT Repair Kit units worldwide to implement point-of-use labeling and enhancements to the Instructions for Use.
Covidien is voluntarily withdrawing the Palindrome RT Repair Kit 15 FR TAL 28cm to improve point-of-use labeling and Instructions for Use. No illnesses or injuries have been reported.
Covidien, LP is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to improve point-of-use labeling and instructions for use. The withdrawal affects devices distributed worldwide.
Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to implement point-of-use labeling and enhanced instructions for use on all affected units.
Covidien is voluntarily withdrawing the Palindrome RT Repair Kit (Lot 1925300162) worldwide to implement improved point-of-use labeling and enhanced Instructions for Use (IFU).
Covidien is voluntarily withdrawing specific lots of Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and enhancements to device instructions for use.
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to implement point-of-use labeling and enhanced instructions for use. No illnesses or injuries have been reported.
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance Instructions for Use.
Covidien is voluntarily withdrawing Palindrome RT Chronic Catheter Kit devices worldwide to implement point-of-use labeling and enhanced Instructions for Use.