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Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm recallZ-1850-2015 · Covidien LLC · initiated Apr 23, 2015

Class II Terminated All recalls posted in July 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

Catheters may not meet antimicrobial specification

FDA root cause category: Nonconforming Material/Component

What the company is doing

Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878. For questions regarding this recall call 203-492-5000.

Recall details

Recall number
Z-1850-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 23, 2015
Posted by the FDA
Jul 1, 2015
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally
Product code
NYU
FDA submissions
K060972, K112477
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

Product description

Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion.

Code information (models, lots, serial numbers)

Item codes identified with an expiry date of February 2018 and earlier

Other devices under the same FDA submission

35 devices cleared under K060972, K112477 — 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 70985).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page