FDA-Device2014-12-17Class II
ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.
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
83 units
Manufactured in
1815 Aston Ave Ste 106, N/A, Carlsbad, CA, United States
Products
ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0565-2015Don't want to check this manually?
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