Codman & Shurtleff, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0846-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Product Classification:

Class II

Date Initiated: January 11, 2013

Date Posted: February 27, 2013

Recall Number: Z-0846-2013

Event ID: 64158

Reason for Recall:

Sterility of device may be compromised due to lack of package integrity

Status: Terminated

Product Quantity: 234 units

Code Information:

All unexpired lots

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated