FDA-Device2015-12-02Class II
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
Covidien LLC
Hazard
Incorrectly packaged with a 90 degree bend at the distal tip
Sold states
Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.
Affected count
10 units
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0333-2016Don't want to check this manually?
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