Recall Z-0812-06 ยท KRK Manometer, Blood-Pressure, Venous
Medex Inc
MX441B, CVP Manometer. The product is packaged in a cardboard box. The units are packed ten (10) per case. The product is labeled on the outer case with a stick-on label that reads in part, ''**medex Dublin, OH 43016 USA**STERILE***MX441B CVP Manometer**Lot#***Latex Free''
| 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(s) telephone the firm and obtain a Return Authorization number in order to return the recalled product. |
| Quantity | 6910 devices |
| Distribution | The recalled device was distributed to customers throughout the U.S.A. and in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904674 | CENTRAL VENOUS PRESSURE MANOMETER Medex, Inc., Dec 27, 1990 |