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Recall Observatory FDA recall evidence

Device product

Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P

Z-1878-2015

April 23, 2015

Class II

Product summary

Firm
Covidien LLC
Event
Event 70985
Status
Terminated
Classification
Class II
Quantity
72,363 US - 24,631 Internationally
Official record key
device-enforcement:Z-1878-2015

Official wording

Reason: Catheters may not meet antimicrobial specification

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

Distribution pattern: 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.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    may not meet antimicrobial specification