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U.S. Department of Health and Human Services

Class 2 Device Recall Codman

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  Class 2 Device Recall Codman see related information
Date Initiated by Firm November 30, 2010
Date Posted April 20, 2011
Recall Status1 Terminated 3 on March 14, 2013
Recall Number Z-2033-2011
Recall Event ID 57340
Product Classification device, monitoring, intracranial pressure - Product Code GWM
Product Codman Plastic Disposable ICP Kit, Complete, Adult Product Code 80-1197

This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
Code Information Lot code LA216
Recalling Firm/
Manufacturer		 Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham MA 02767
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 44 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
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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