FDA-Device2015-07-08Class II

Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP

Covidien LLC
Hazard

Catheters may not meet antimicrobial specification

Sold states
Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.
Affected count
72,363 US - 24,631 Internationally
Manufactured in
60 Middletown Ave, North Haven, CT, United States
Products
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1879-2015

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