Pfm Medical Inc: Medical Device Recall in 2014 - (Recall #: Z-0562-2015)

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 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.

Product Classification:

Class II

Date Initiated: October 20, 2014

Date Posted: December 17, 2014

Recall Number: Z-0562-2015

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: 1470 units

Code Information:

Lot No. 1307-065, 1301-009

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