Angiotech, Bone Marrow Harvest Needle, Medical Device Technologies, Inc. The device is intended for use Bone Marrow Biop
FDA device recall Z-0453-2009 · posted 2009-01-06 · Terminated
Recall details
- Recalling firm
- Medical Device Technologies, Inc.
- Reason for recall
- Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.
- Action taken
- Each consignee was notified of recall by letter on 07/16/2008 . The letter described the problem and indicated the corrective action to be taken. A Customer Acknowledgment Form with request to fax form to firm's QA Dept was provided. Contact Medical Device Technologies, Inc., Quality Assurance Department at 1.352.338.0440, ext 350 and 353 for assistance.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 130 units
- Distribution
- Nationwide - FL, TX, WI, PA, MN, SC, NC, KY, TN, CA, AR, OR, NJ, and IA.
- Date initiated
- 2008-07-16
- Date posted
- 2009-01-06
- Date terminated
- 2009-04-21
- Location
- Gainesville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MD TECH BIOPSY SET FOR BONE AND BONE MARROW (K980196) | Medical Device Technologies, Inc. | 1998-02-03 |