FDAFDA · Food and drugs·Recall number Z-2373-2021
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
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: 1727100082 1804000124 1908400303 2001400121 1730500134 1805900129 1926100248 2009300116 1732700146 1816400078 1926100292 2023300132 1734700118 1823400098 1931600117 2027200192 1801000131 1902800150
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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