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Pfm Medical Inc recalls ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical
Recalled December 17, 2014 · FDA recall Z-0561-2015 · Pfm Medical
Hazard
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. · FDA Class II
Units
120 units
Sold at
Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
Description
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Product
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.
Manufacturer(s)
Pfm Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →