FDA-Device2014-12-17Class II
6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.
Pfm Medical Inc
Hazard
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Sold states
Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
Affected count
90 units
Manufactured in
1815 Aston Ave Ste 106, N/A, Carlsbad, CA, United States
Products
6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0564-2015Don't want to check this manually?
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