Recall Z-0853-2013— Codman & Shurtleff, Inc.

Name: FDA recall Z-0853-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-11

Class II · Terminated

Class II FDA medical device recall by Codman & Shurtleff, Inc., initiated 2013-01-11, terminated 2015-08-10. It names one FDA 510(k) clearance: K052004. Product: NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices. Reason: Sterility of device may be compromised due to lack of package integrity.

Recalling firm: Codman & Shurtleff, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-11
Terminated: 2015-08-10
Firm location: Raynham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K052004 — VASCON NEUROPATH GUIDING CATHETERVascon, LLC·cleared 2006-01-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.