Home / Recalls / Pfm Medical Inc / Z-0563-2015

Z-0563-2015 Class II Terminated

Recalled by Pfm Medical Inc — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
December 17, 2014
Initiation Date
October 20, 2014
Termination Date
April 23, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
100 units

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.

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.

Code Information

Lot No. 1302-014

Other recalls by Pfm Medical Inc

  • Z-0560-2015 Class II — Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: (October 20, 2014)
  • Z-0566-2015 Class II — Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Us (October 20, 2014)
  • Z-0562-2015 Class II — ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Dra (October 20, 2014)
  • Z-0568-2015 Class II — ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage (October 20, 2014)
  • Z-0564-2015 Class II — 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC (October 20, 2014)
  • Z-0561-2015 Class II — ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, (October 20, 2014)
  • Z-0567-2015 Class II — Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peri (October 20, 2014)
  • Z-0565-2015 Class II — ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm m (October 20, 2014)