Recall Z-0568-2015— Pfm Medical Inc

Name: FDA recall Z-0568-2015
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 2 FDA 510(k) clearances: K113354, K093796. 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.. 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

2 on FDA's record

K113354 — VETA PERITONEAL DIALYSIS CATHETERPfm Medical, Inc.·cleared 2012-03-13
K093796 — ASEPT PERITONEAL DRAINAGE SYSTEMPfm Medical, Inc.·cleared 2010-02-26

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 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.

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.