FDAFDA · Food and drugs·Recall number Z-2374-2021
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
Published September 8, 2021 · Recall initiated: May 28, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien, LP
- Distributor
- Worldwide distribution.
- Lot
- Lot Numbers: 1729700119 1817700205 1910600266 2014900148 1810400147 1828900137 2014900151 2034400131
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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