FDA-Device2014-12-17Class II

Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage

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
480 units
Manufactured in
1815 Aston Ave Ste 106, N/A, Carlsbad, CA, United States
Products
Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0560-2015

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