Recall Z-2032-2011
Codman & Shurtleff, Inc. · initiated November 30, 2010
Product
Codman Cranial Hand Drill Product Code: 82-6607 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: 429084 429085 429086 430880 430881 430882 430883 430884 430885 430886 434297 434298 434299 JA272 JA296 JA238 KA230 KA265 LA212 LA247 LA279 MA215 MA254 MA299 AB207 AB288 AB289 BB312 CB250 DB203 DB204 DB207 EB328 EB329 EB343 EB344 FB232 422690 422691 422692 422693 422694 422695 422696 422697 422698 422699 422700 425478 424537 429080 429081 429082 429083 FB238 FB345 GB204 GB205 GB206 GB287 HB201 HB202 HB280 JB200 JB288 KB210 KB276 KB277 LB253 LB303 LB304 MB255
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-2032-2011
- Initiated
- November 30, 2010
- Posted by FDA
- April 20, 2011
- Terminated
- March 14, 2013
- Product code
- GWM – Device, Monitoring, Intracranial Pressure
- Quantity
- 9038 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-2031-2011 | Codman Plastic Disposable ICP Kit, Adult Product Code: 80-1196 This is a single use…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 |