MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a
FDA device recall Z-0811-06 · posted 2006-04-26 · Terminated
Recall details
- Recalling firm
- Medex Inc
- Reason for recall
- The product is labeled as 'Latex Free'; however, one of the components of the finished product may contain latex.
- Action taken
- The firm sent a recall letter dated 11/18/2005, via Certified mail to all of their customers. In the letter, the firm requests that the consignee telephone the firm and obtain a Return Authorization number in order to return the recalled product.
- Root cause
- Other
- Status
- Terminated
- Product code
- GWM
- Quantity affected
- 2480 devices
- Distribution
- The recalled device was distributed to a single direct account customer located in Alabama and to
- Date initiated
- 2005-11-18
- Date posted
- 2006-04-26
- Date terminated
- 2008-01-22
- Location
- Dublin, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRACRANIAL PRESSURE MONITORING DEVICE (K822864) | Medex, Inc. | 1982-11-16 |