Pfm Medical Inc: Medical Device Recall in 2014 - (Recall #: Z-0563-2015)

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:

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.

Product Classification:

Class II

Date Initiated: October 20, 2014

Date Posted: December 17, 2014

Recall Number: Z-0563-2015

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: 100 units

Code Information:

Lot No. 1302-014

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