CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm Product code: ENF452812

FDA device recall Z-2701-2011 · posted 2011-06-29 · Terminated

Recall details

Recalling firm

Codman & Shurtleff, Inc.

Reason for recall

Mislabeled: One of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length.

Action taken

Codman & Shurtleff, Inc.sent an "Urgent Medical Device Correction Notice" on March 21, 2011. The letter recommend the incorrect label be removed and discarded. There are 3 additional peel-off labels, 2 on the outer box and one on the pouch. All 3 of these contain the correct printed size information (28 mm) that can be used for applying to the inventory sheet, patient record or patient card, as needed. It is NOT required to return any of this product to Codman. Customer Service at 1-800-225-0460 or contact your local Codman Neurovascular Representative

Root cause

Labeling design

Status

Terminated

Product code

NJE

Quantity affected

380 units

Distribution

Worldwide - Nationwide (USA), Canada, Korea.

Date initiated

2011-03-21

Date posted

2011-06-29

Date terminated

2016-02-17

Location

Raynham, MA