Recall Z-0811-06 ยท GWM Device, Monitoring, Intracranial Pressure
Medex Inc
MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch with a stick-on label that reads in part ,''medex Dublin, OH 43016 USA***STERILE**MX6160R1 ** Custom CIPER**Lot #:**Latex Free***SINGLE USE''
| Date | Apr 26, 2006 (initiated Nov 18, 2005) |
| Status | Terminated |
| Reason | The product is labeled as 'Latex Free'; however, one of the components of the finished product may contain latex. |
| Root cause | Other |
| Action | 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. |
| Quantity | 2480 devices |
| Distribution | The recalled device was distributed to a single direct account customer located in Alabama and to |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K822864 | INTRACRANIAL PRESSURE MONITORING DEVICE Medex, Inc., Nov 16, 1982 |