The Recall Desk
ModerateFDA (Devices)·Z-2364-2021·Announced 2021-09-08

Palindrome RT Repair Kit Voluntary Withdrawal for Labeling and Instructions Enhancement

Covidien voluntarily withdrew Palindrome RT Repair Kit units worldwide to implement point-of-use labeling and enhancements to the Instructions for Use.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a voluntary, precautionary FDA Class II withdrawal for labeling and instruction enhancements with no reported illnesses or injuries, consistent with Moderate severity per the rubric.

Plain-English summary

Covidien, LP has announced a voluntary withdrawal of Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile (Item Code 8888541119). The withdrawal is being conducted to implement point-of-use labeling on each device and to make enhancements to the Instructions for Use (IFU).

Affected units have lot numbers 1708800198, 1714400174, 1904900098, and 2009300086. The product was distributed worldwide.

This is a voluntary measure to improve product labeling and instructions.

The recalled product

Product
Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
Manufacturer
Covidien, LP
Category
Medical Device — Repair Kit
Hazard
  • labeling
  • instructions

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: 1708800198 1714400174 1904900098 2009300086

Distribution

Distribution scope not specified by the agency.

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