Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458
FDA Recall Z1856-2015 · Posted 2015-07-01
Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeNYU
Date Initiated2015-04-23
Date Terminated2017-07-26
Product Quantity72,363 US - 24,631 Internationally
Reason for Recall
Catheters may not meet antimicrobial specification
Firm Action
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.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.