FDAClass IIJuly 8, 2015

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet recall: Contamination

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C

Why was Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet recalled?

Catheters may not meet antimicrobial specification

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C
Recalling firm
Covidien LLC
Quantity
72,363 US - 24,631 Internationally
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.
Recall date
July 8, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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