Recall Z-0451-2009 ยท KNW Instrument, Biopsy
Medical Device Technologies, Inc.
Angiotech, Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.
| Date | Jan 6, 2009 (initiated Jul 16, 2008) |
| Status | Terminated |
| Reason | Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray. |
| Root cause | Other |
| Action | 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. |
| Quantity | 60 units |
| Distribution | Nationwide - FL, TX, WI, PA, MN, SC, NC, KY, TN, CA, AR, OR, NJ, and IA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980196 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW Medical Device Technologies, Inc., Feb 3, 1998 |