Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw,, Adult Product Code:80-1196 Produ
FDA device recall Z-0709-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Codman & Shurtleff, Inc.
- Reason for recall
- Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.
- Action taken
- Codman issued an Urgent Medical Device Correction Notice dated October 25, 2011 to all affected customers. The notice identified the product, problem, and actions to be taken. Customers were instructed to notify all appropriate personnel of the correction notice. The notice instructs customers to fax the attached acknowledgement form to 508-977-6403. For questions call your Customer Service or contact your local Codman representative.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- GWM
- Quantity affected
- 462 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of: Dubai, Mexico, Panama, Spain and Uruguay.
- Date initiated
- 2011-10-25
- Date posted
- 2012-01-11
- Date terminated
- 2015-05-29
- Location
- Raynham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT (K853770) | Codman & Shurtleff, Inc. | 1986-10-06 |