FDA Medical Device Recalls (openFDA)
Medical Device Technologies, Inc.: 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
- Recall number
- Z-0952-04
- 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
- Status
- Terminated
- Initiated
- 2004-03-02
- Posted
- 2004-07-20
- Terminated
- 2012-07-07
- Reason
- The outer plastic blister packagiing material may be cracked thereby compromising the device's sterility barrier.
- 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
- 10,303
- Distribution
- The devices were distributed to 586 domestic medical facilites nationwide and to 13 international accounts.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAA
- Firm FEI
- 1036710
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28