NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovascul

FDA device recall Z-0858-2013 · posted 2013-02-20 · Terminated

Recall details

Recalling firm

Codman & Shurtleff, Inc.

Reason for recall

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

Action taken

Codman sent an Urgent Voluntary Product Recall Notification letter dated January 11, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to check all inventory to determine if they have any affected product, use the included instructions to report inventory status, return and obtain replacement product. Customers were instructed to contact your local Codman Representative or Stericycle at 1-866-201-9077. For questions regarding this recall call 508-880-8100.

Root cause

Component design/selection

Status

Terminated

Product code

DQY

Quantity affected

46 units

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Ma

Date initiated

2013-01-11

Date posted

2013-02-20

Date terminated

2015-08-10

Location

Raynham, MA

Related 510(k) clearances