Recall Z-0565-2015— Pfm Medical Inc

Name: FDA recall Z-0565-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-20

Class II · Terminated

Class II FDA medical device recall by Pfm Medical Inc, initiated 2014-10-20, terminated 2015-04-23. It names one FDA 510(k) clearance: K083873. Product: 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.. Reason: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin..

Recalling firm: Pfm Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2014-10-20
Terminated: 2015-04-23
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K083873 — PICC (CT RATED AND NON-RATED)Pfm Medical, Inc.·cleared 2009-03-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

Data sourced from openFDA. This site is unofficial and independent of the FDA.