| Class 2 Device Recall Codman | |
Date Initiated by Firm | November 30, 2010 |
Date Posted | April 20, 2011 |
Recall Status1 |
Terminated 3 on March 14, 2013 |
Recall Number | Z-2030-2011 |
Recall Event ID |
57340 |
Product Classification |
device, monitoring, intracranial pressure - Product Code GWM
|
Product | Codman Metal Disposable ICP Kit
Product Code: 80-1190
This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures |
Code Information |
Lot Codes: 421298 422002 SW103730 444161 KA291 AB243 DB319 FB302 JB212 |
Recalling Firm/ Manufacturer |
Codman & Shurtleff, Inc. 325 Paramount Drive Raynham MA 02767
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For Additional Information Contact | SAME 508-828-3532 |
Manufacturer Reason for Recall | Packaging defect may compromise sterility of device |
FDA Determined Cause 2 | Package design/selection |
Action | 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. |
Quantity in Commerce | 1671 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, Mexico, New Zealand, Saudia Arabia, UAE, Uruguay, and United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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