Recall Z-2031-2011
Codman & Shurtleff, Inc. · initiated November 30, 2010
Product
Codman Plastic Disposable ICP Kit, Adult Product Code: 80-1196 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
Codes / lots: Lot Codes: 404206 426891 KA209 MB270
Reason for recall
Packaging defect may compromise sterility of device
FDA-determined cause: Package design/selection
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.
Details
- Recall number
- Z-2031-2011
- Initiated
- November 30, 2010
- Posted by FDA
- April 20, 2011
- Terminated
- March 14, 2013
- Product code
- GWM – Device, Monitoring, Intracranial Pressure
- Quantity
- 226 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.
- Recalling firm
- Codman & Shurtleff, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2028-2011 | Codman Disposable Twist Drill Product code: 80-1200 This is a single use, disposable…Packaging defect may compromise sterility of device | 11/30/2010Terminated |
| Z-2029-2011 | Ghajar Guide Ventriculostomy Kit Product Code: 80-1185 This is a single use, disposable…Packaging defect may compromise sterility of device | 11/30/2010Terminated |
| Z-2030-2011 | Codman Metal Disposable ICP Kit Product Code: 80-1190 This is a single use, disposable…Packaging defect may compromise sterility of device | 11/30/2010Terminated |
| Z-2032-2011 | Codman Cranial Hand Drill Product Code: 82-6607 This is a single use, disposable drill…Packaging defect may compromise sterility of device | 11/30/2010Terminated |
| Z-2033-2011 | Codman Plastic Disposable ICP Kit, Complete, Adult Product Code 80-1197 This is a single…Packaging defect may compromise sterility of device | 11/30/2010Terminated |