MX441B, CVP Manometer. The product is packaged in a cardboard box. The units are packed ten (10) per case. The product i
FDA device recall Z-0812-06 · 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(s) telephone the firm and obtain a Return Authorization number in order to return the recalled product.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRK
- Quantity affected
- 6910 devices
- Distribution
- The recalled device was distributed to customers throughout the U.S.A. and in Canada.
- Date initiated
- 2005-11-18
- Date posted
- 2006-04-26
- Date terminated
- 2007-05-07
- 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 |
|---|---|---|
| CENTRAL VENOUS PRESSURE MANOMETER (K904674) | Medex, Inc. | 1990-12-27 |