Recall Z-0329-2016— Covidien LLC

Name: FDA recall Z-0329-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-14

Class II · Terminated

Class II FDA medical device recall by Covidien LLC, initiated 2015-10-14, terminated 2017-06-02. It names one FDA 510(k) clearance: K123196. Product: Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 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.. Reason: Incorrectly packaged with a 90 degree bend at the distal tip.

Recalling firm: Covidien LLC
Classification: Class II
Status: Terminated
Initiated: 2015-10-14
Terminated: 2017-06-02
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K123196 — PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATHCovidien·cleared 2013-01-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 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.

Reason for recall

Incorrectly packaged with a 90 degree bend at the distal tip

Data sourced from openFDA. This site is unofficial and independent of the FDA.