Recall Z-2029-2011 ยท GWM Device, Monitoring, Intracranial Pressure
Codman & Shurtleff, Inc.
Ghajar Guide Ventriculostomy Kit Product Code: 80-1185 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
| Date | Apr 20, 2011 (initiated Nov 30, 2010) |
| Status | Terminated |
| Reason | Packaging defect may compromise sterility of device |
| Root cause | 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 advi |
| Quantity | 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, Mexico, New Zealand, Saudia Arabia, UAE, Uruguay, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K853770 | CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT Codman & Shurtleff, Inc., Oct 6, 1986 |