Recall Z-0562-2015— Pfm Medical Inc

Name: FDA recall Z-0562-2015
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: K093307. Product: ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or 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

K093307 — ASEPT PLEURAL DRAINAGE SYSTEMPfm Medical, Inc.·cleared 2009-11-06

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 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or 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.