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[Recalled] Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P — This voluntary withdrawal is being conducted to implement point-of-use labeling… | FDA 2021-05-28

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductPalindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
Brand / manufacturerCovidien, LP
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2373-2021
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date28 May 2021
EAN / barcode1727100082

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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