Angiotech, Bone Marrow Harvest Needle, Medical Device Technologies, Inc. The device is intended for use Bone Marrow Biopsy.
FDA Recall Z-0453-2009 · Posted 2009-01-06
Advertisement
Recalling FirmMedical Device Technologies, Inc.
Recall StatusTerminated
Product CodeKNW
Date Initiated2008-07-16
Date Terminated2009-04-21
Product Quantity130 units
Reason for Recall
Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide - FL, TX, WI, PA, MN, SC, NC, KY, TN, CA, AR, OR, NJ, and IA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement