Pfm Medical Inc: Medical Device Recall in 2014 - (Recall #: Z-0561-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 20, 2014

Date Posted: December 17, 2014

Recall Number: Z-0561-2015

Event ID: 69666

Reason for Recall:

PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

Status: Terminated

Product Quantity: 120 units

Code Information:

Lot No. 1307-024, 1302-031, 1210-015

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated