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Pfm Medical Inc recalls ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal draina

Recalled December 17, 2014 · FDA recall Z-0568-2015 · 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
370 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 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.
Manufacturer(s)
Pfm Medical Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Pfm Medical Inc recalls ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal draina | RecallWatchUSA