Recall Z-0564-2015— Pfm Medical Inc

Name: FDA recall Z-0564-2015
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: 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.. 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

6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.

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.