Z-2364-2021 Class II Ongoing
FDA device recall Z-2364-2021 was initiated by Covidien, LP on May 28, 2021 and is designated Class II. Reason for recall: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- September 8, 2021
- Initiation Date
- May 28, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
Reason for Recall
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Distribution Pattern
Worldwide distribution.
Code Information
Lot Numbers: 1708800198 1714400174 1904900098 2009300086