FDA Enforcement
Class II
Ongoing
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
Recall: Z-2361-2021
·
Reported September 8, 2021
Enforcement
- Recall Number
- Z-2361-2021
- Event ID
- 88250
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Covidien, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 8, 2021
- Initiation Date
- May 28, 2021
- Classification Date
- August 27, 2021
- Address
- 60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States
Description
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
Reason
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
Code Info
Lot Numbers: 1800300145 1814300204 2009300078 2027200251 1805900115 1926100256 2017500135
Distribution
Worldwide distribution.
Quantity
N/A