Device product
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.
Z-1850-2015
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-1850-2015
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
may not meet antimicrobial specification