Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888
Summary
The FDA issued a Class II for Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 1 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-2371-2021
Action Date
2021-09-08
Status
Ongoing
Category
device
Product Description
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
Lot/Code Info: Lot Numbers: 1724200116 1815000199 1921300032 1932300191 1725600107 1815800076 1921300034 1932300192 1727100076 1817100090 1927500067 2023300141 1728600062 1817700206 1929400086 2027200174 1734700104 1826800141 1929500067 2026000073 1801000128 1831600197 1929500068 2028200214 1802400119 1833100112 1929500071 2028200215 1804000126 1905600140 1929500088 2033100065 1805200078 1906000165 1929500089 2032800041 1806600074 1908400286 1929500072 2034400102 1807300167 1906700185 1930900073 1808600066 1920500223 1930900074
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-2371-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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