FDA Medical Device Recalls (openFDA)
Covidien LLC: Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C
- Recall number
- Z-1863-2015
- Recalling firm
- Covidien LLC
- Product
- Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C
- Status
- Terminated
- Initiated
- 2015-04-23
- Posted
- 2015-07-01
- Terminated
- 2017-07-26
- Reason
- Catheters may not meet antimicrobial specification
- Root cause
- Nonconforming Material/Component
- 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.
- 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.
- Lot, serial or model codes
- Item codes identified with an expiry date of February 2018 and earlier
- 510(k) numbers
- ["K060972","K112477"]
- PMA numbers
- not on file
- Product code
- NYU
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28