Home / Recalls / Pfm Medical Inc / Z-0561-2015

Z-0561-2015 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
120 units

Product Description

ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.

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. 1307-024, 1302-031, 1210-015

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-0563-2015 Class II — Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: T (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-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)