Covidien recalls Palindrome RT Repair Kit 15 FR TAL 55cm (Item Code 8888541155) for point-of-use labeling updates to improve safety. No immediate action required as this is a labeling enhancement, not a safety hazard.
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Covidien is recalling a specific type of Palindrome RT Repair Kit for labeling updates. This recall does not involve a safety hazard but aims to improve instructions for use and labeling.
The recall involves updating labeling and instructions for use to ensure proper handling. This is not a safety hazard but a procedural improvement to align with current best practices.
Users of the Palindrome RT Repair Kit 15 FR TAL 55cm (Item Code 8888541155) with Lot Number 1925300162 are affected. Healthcare professionals using this kit for medical procedures may need updated labeling.
Check for the item code 8888541155 and Lot Number 1925300162 on the Palindrome RT Repair Kit 15 FR TAL 55cm. This kit is sold by Covidien, LP.
Covidien will provide updated labeling and instructions for use for the recalled kit. No action is needed beyond checking the label.
No, this recall is for labeling updates and does not involve a safety hazard.
No, the recall does not require stopping use. This is a labeling enhancement for improved instructions.
No action is required. The recall involves updating labeling and instructions, not discarding the product.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2369-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2369-2021 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.
