Recall Z-0451-2009
Medical Device Technologies, Inc. · initiated July 16, 2008
Product
Angiotech, Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.
Codes / lots: Lot Number 81371NGF and 81081MRM.
Reason for recall
Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-0451-2009
- Initiated
- July 16, 2008
- Posted by FDA
- January 6, 2009
- Terminated
- April 21, 2009
- Product code
- KNW – Instrument, Biopsy
- Quantity
- 60 units
- Distribution
- Nationwide - FL, TX, WI, PA, MN, SC, NC, KY, TN, CA, AR, OR, NJ, and IA.
- Recalling firm
- Medical Device Technologies, Inc., Gainesville, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0450-2009 | Angiotech, Bone Marrow Aspiration Needle, Medical Device Technologies, Inc. Individual…Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray. | 07/16/2008Terminated |
| Z-0452-2009 | Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device…Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray. | 07/16/2008Terminated |
| Z-0453-2009 | Angiotech, Bone Marrow Harvest Needle, Medical Device Technologies, Inc. The device is…Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray. | 07/16/2008Terminated |