Recall Z-0563-2015— Pfm Medical Inc

Name: FDA recall Z-0563-2015
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: Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. 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.. 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

Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. 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.

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.