Recalls / —
—#136022
Product
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057CP
- FDA product code
- MSD — Catheter, Hemodialysis, Implanted
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K062671, K112477, K123196
- Affected lot / code info
- Item codes identified with an expiry date of February 2018 and earlier
Why it was recalled
Catheters may not meet antimicrobial specification
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Covidien LLC
- Address
- 60 Middletown Ave, North Haven, Connecticut 06473-3908
Distribution
- 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.
Timeline
- Recall initiated
- 2015-04-23
- Posted by FDA
- 2015-07-01
- Terminated
- 2017-07-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #136022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.