Summary
The FDA issued a Class II for Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm by Covidien LP. Reason: Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is ident.
Details
Source
Device Recall
External ID
Z-2632-2023
Action Date
2023-10-04
Status
Ongoing
Category
device
Product Description
Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Lot/Code Info: UDI-DI: 10884521013162, 20884521013169; Lot Numbers: 2221700131, 2224200233, 2230400271, 2230400272
Quantity Affected: 3050 devices
Reason for Recall
Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body.
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Puerto Rico, Spain, Thailand, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-22
Company
Mansfield, MA
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 143 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-2632-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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