Ghajar Guide Ventriculostomy Kit Product Code: 80-1185 This is a single use, disposable drill kit designed for gaining a

FDA device recall Z-2029-2011 · posted 2011-04-20 · Terminated

Recall details

Recalling firm

Codman & Shurtleff, Inc.

Reason for recall

Packaging defect may compromise sterility of device

Action taken

The firm, Codman, sent an "Important Notice Urgent- Voluntary Product Recall Notification" letter dated November 30, 2010 to its customers via FedX. On January 7, 2011, Codman expanded the recall to four additional product codes.On January 31, 2011, the firm issued a supplemental recall letter and identified one additional product code: 80-11197. The letters described the product, problem and actions to be taken. The customers were instructed to identify the unused affected products in their inventory and follow the recall instructions provided: 1) If you have NO product to return, please advise Codman as soon as possible using the FACSIMILE form attached and fax to 508-828-6118 and 2) if you DO have product to return, please call 1-800-225-0460, Option 4, for instructions for return. Codman is presently working toward supplying replacement products as soon as possible. Please call Customer Service to check on the status of product availability at 1-800-225-0460. Should you have any questions regarding this recall, please call Customer Service at 1-800-225-0460 or your local Codman Representative.

Root cause

Package design/selection

Status

Terminated

Product code

GWM

Quantity affected

2264 units

Distribution

Worldwide distribution: USA including states of :AL, FL,GA, KY, MA, MI, MN, MS, OR, PA, RI, UT,WI and WV; and countries including: Argentina, Australia, Canada, Bahamas , Belgium, Dubai, Japan, Madrid

Date initiated

2010-11-30

Date posted

2011-04-20

Date terminated

2013-03-14

Location

Raynham, MA

Related 510(k) clearances