FDA-Device2023-10-04Class II
Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Covidien LP
Hazard
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.
Sold states
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.
Affected count
3050 devices
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2632-2023Don't want to check this manually?
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