Home / Recalls / Pfm Medical Inc / Z-0566-2015

Z-0566-2015 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
75 units

Product Description

Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.

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. 1212-001, 1212-034

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-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-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)