PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 2, 2015 Initiated: October 14, 2015 #Z-0333-2016

Product Description

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.

Reason for Recall

Incorrectly packaged with a 90 degree bend at the distal tip

Details

Recalling Firm
Covidien LLC
Units Affected
10 units
Distribution
Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.
Location
North Haven, CT

Frequently Asked Questions

What product 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.. Recalled by Covidien LLC. Units affected: 10 units.
Why was this product recalled?
Incorrectly packaged with a 90 degree bend at the distal tip
Which agency issued this recall?
This recall was issued by the FDA Devices on December 2, 2015. Severity: Moderate. Recall number: Z-0333-2016.