Summary
The FDA issued a Class II for Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128 by Covidien, LP. Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU)..
Details
Source
Device Recall
External ID
Z-2366-2021
Action Date
2021-09-08
Status
Ongoing
Category
device
Product Description
Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
Lot/Code Info: Lot Numbers: 1834500202 1920500219 2014900143 2020400107 1914800210 2009300121 2017500133 2023300110
Quantity Affected: N/A
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
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-28
Company
North Haven, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 126 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien, LP has 89 FDA actions in our database, including 89 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien, LP have FDA actions?
Covidien, LP has 89 FDA actions in our database, including 89 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2366-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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