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Palindrome Precision Chronic Catheter Kit Symmetrical Tip… recallZ-0331-2016 · Covidien LLC · initiated Oct 14, 2015

Class II Terminated All recalls posted in November 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Incorrectly packaged with a 90 degree bend at the distal tip

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-0331-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 14, 2015
Posted by the FDA
Nov 24, 2015
Recalling firm
Covidien LLC
Quantity
365 units
Product code
NYU
FDA submissions
K123196
Distribution
Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.

Product description

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

Code information (models, lots, serial numbers)

Lot Numbers: 1504700102, 1516900090, 1425000091

Other devices under the same FDA submission

70 devices cleared under K123196 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 72416).

Sources and updates

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