Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
Summary
The FDA issued a Class II for Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5 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-2360-2021
Action Date
2021-09-08
Status
Ongoing
Category
device
Product Description
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
Lot/Code Info: Lot Numbers: 1726500092 1806600073 1833800146 2009200089 1728600060 1815800078 1904900089 2012100138 1733300161 1816400084 1906300059 2020400105 1733700172 1826200176 1910200093 2026000059 1733700178 1826800155 1917600105 2027200241 1800300143 1828200124 1926100255 2028200207 1804000125 1831000115 1931600120 2028200207 1804500144 1832300108 2000700070
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-2360-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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