FDAFDA · Food and drugs·Recall number Z-1904-2015
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369
Published July 8, 2015 · Recall initiated: April 23, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Catheters may not meet antimicrobial specification
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien LLC
- Distributor
- 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
- Item codes identified with an expiry date of February 2018 and earlier
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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