Z-0952-04

BioPince Full Core Biopsy Instrument packed in aTyvek/plastic blister pack which is labeled as previously...

Name: Z-0952-04 BioPince Full Core Biopsy Instrument packed in aTyvek/plastic blister pack which is labeled as previously...
Creator: Medical Device Technologies, Inc.
Published: 2004-03-02
License: https://open.fda.gov/license/

Medical Device Technologies, Inc. / initiated 2004-03-02 / Terminated / root cause: packaging

FDA source

Medical Device Technologies, Inc. began a recall of BioPince Full Core Biopsy Instrument packed in aTyvek/plastic blister pack which is labeled as previously stated and also in a cardboard shelf carton labeled... on 2004-03-02. The reason FDA records is "The outer plastic blister packagiing material may be cracked thereby compromising the device's sterility barrier". 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-0952-04
Status: Terminated
Initiated: 2004-03-02
Posted: 2004-07-20
Terminated: 2012-07-07
Recalling firm: Medical Device Technologies, Inc.
Product: BioPince Full Core Biopsy Instrument packed in aTyvek/plastic blister pack which is labeled as previously stated and also in a cardboard shelf carton labeled as MDTECH Gainesville, Florida 32608 BioPince FULL CORE BIOPSY INSTRUMENT ga. cm REF: Lot
Product code: GAA Needle, Aspiration And Injection, Disposable
Reason for recall: The outer plastic blister packagiing material may be cracked thereby compromising the device's sterility barrier.
Root cause tag: packaging
FDA root cause: Other
Action: The firm mailed a recall letter to accounts on 3/2/2004 asking each account to inspect their in stock product for damage and to to notify the recalling firm and return product. Also the firm enclosed a response card in a self addressed postage paid envelope.
Quantity in commerce: 10,303
Distribution: The devices were distributed to 586 domestic medical facilites nationwide and to 13 international accounts.
Product codes and lots: PART NUMBER LOT NUMBER 360-1080-01 24821 360-1080-01 30531 360-1080-01 30811 360-1080-01 30923 360-1080-02 24821 360-1080-01 31251 360-1080-01 32211 360-1080-01 32842 360-1080-01 32851-1 360-1080-01 32851-2 360-1080-01 33451 360-1080-01 33452 360-1080-01 33832 360-1080-01 34031 360-1080-01 34331 360-1080-01 34512 360-1080-01 34721 360-1580-01 30633 360-1580-01 31042 360-1580-01 32032 360-1580-01 32341 360-1580-01 32852 360-1580-01 33433 360-1580-01 33434 360-1580-01 34232 360-1580-01 34931 360-1580-01 32852-2 360-2080-01 30751 360-2080-01 30811 360-2080-01 31531 360-2080-01 33331 360-2080-01 33332 360-2080-01 34221 360-2080-01 34322 360-2080-01 34734 360-2080-01 34941 363-1080-01 32431 364-1080-01 34549 364-1580-01 34432 370-1080-01 33932 370-1080-01 35032 370-1580-01 34447 370-1580-01 35021

Product code GAA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)