Pfm Medical Inc: Medical Device Recall in 2014 - (Recall #: Z-0564-2015)

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:

6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage: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. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.

Product Classification:

Class II

Date Initiated: October 20, 2014

Date Posted: December 17, 2014

Recall Number: Z-0564-2015

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: 90 units

Code Information:

Lot No. 1301-038

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