Z-0329-2016Class II

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

Name: Z-0329-2016 Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item...
Creator: Covidien LLC
Published: 2015-10-14
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-10-14 / Terminated / root cause: packaging

FDA source

Covidien LLC began a recall of 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... on 2015-10-14. FDA classified it as Class II and gives the reason as "Incorrectly packaged with a 90 degree bend at the distal tip". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0329-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-14
Posted: 2015-11-24
Terminated: 2017-06-02
Recalling firm: Medtronic, Inc.
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.
Product code: NYU Catheter, Hemodialysis, Implanted, Coated
Reason for recall: Incorrectly packaged with a 90 degree bend at the distal tip
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm, Medtronic (Covidien), sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/16/2015 to their customers. The letter described the product, problem, and actions to be taken. Customers were instructed to quarantine and discontinue use of the product, return affected product and complete and return the RECALLED PRODUCT RETURN FORM via Fax to Medtronic to (800)-895-6140 or email to: [email protected]/Distributor to (203) 492-7719 or email to: [email protected]. Questions or concerns contact your Medtronic representative or Customer Service at (800) 882-5878.
Quantity in commerce: 280 units
Distribution: Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.
Product codes and lots: Lot Numbers: 1503500094, 1431900098, 1435800009

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0329-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0329-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-24
Z-0330-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-24
Z-0331-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-24
Z-0332-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-24
Z-0333-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-24

Product code NYU

K123196Class IIPalindrome Precision H Chronic Catheter, Palindrome Precision Si Chronic Catheter, Palindrome Precision Hsi Chronic CathCovidien / cleared 2013-01-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)