Z-0450-2009

Angiotech, Bone Marrow Aspiration Needle, Medical Device Technologies, Inc. Individual packaged in blister...

Name: Z-0450-2009 Angiotech, Bone Marrow Aspiration Needle, Medical Device Technologies, Inc. Individual packaged in blister...
Creator: Medical Device Technologies, Inc.
Published: 2008-07-16
License: https://open.fda.gov/license/

Medical Device Technologies, Inc. / initiated 2008-07-16 / Terminated / root cause: packaging

FDA source

Medical Device Technologies, Inc. began a recall of Angiotech, Bone Marrow Aspiration Needle, Medical Device Technologies, Inc. Individual packaged in blister pack. Packaged 10 per box. Sterile on 2008-07-16. The reason FDA records is "Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0450-2009
Status: Terminated
Initiated: 2008-07-16
Posted: 2009-01-06
Terminated: 2009-04-21
Recalling firm: Medical Device Technologies, Inc.
Product: Angiotech, Bone Marrow Aspiration Needle, Medical Device Technologies, Inc. Individual packaged in blister pack. Packaged 10 per box. Sterile.
Product code: KNW Instrument, Biopsy
Reason for recall: Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.
Root cause tag: packaging
FDA 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 in commerce: 60 units
Distribution: Nationwide - FL, TX, WI, PA, MN, SC, NC, KY, TN, CA, AR, OR, NJ, and IA.
Product codes and lots: Lot Number 81351NDR

Product code KNW

K980196Class IIMd Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. / cleared 1998-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)