Covidien LLC recalls Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm)…

Recall date

October 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0333-2016

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.

Why it was recalled

Incorrectly packaged with a 90 degree bend at the distal tip

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.