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[Recalled] Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123 — This voluntary withdrawal is being conducted to implement point-of-use labeling… | FDA 2021-05-28

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductPalindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
Brand / manufacturerCovidien, LP
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2365-2021
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date28 May 2021
EAN / barcode1616800188

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Covidien, LP

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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