Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument

• • Ongoing Z-3192-2024 FDA Class II ·initiated 2 Jul 2024

  Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.

• • Terminated Z-0025-2011 FDA Unclassified (pre-2012) ·initiated 2 Jul 2010 ·on shared 510(k) K982960

  Medical Device Technologies, Inc., dba Angiotech, Gaineville, Florida is recalling Tru-Core II Disposable Biopsy Devices due to compromised packaging integrity. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recall is for the following Model Numbers: 763114100X, 763114160X, 763114

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K982960 ↗

FDA Product Code

KNW

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Manan Biliary Drainage Catheter

  Class II

  FDA 510(k) K980191 Active Cleared 9 Feb 1998

• Manan D Bag

  Class II

  FDA 510(k) K980005 Active Cleared 30 Jan 1998

• Ultra-Core Biopsy Needles

  Class I

  FDA 510(k) K921418 Active Cleared 19 Jun 1992

• Techna-Cut Aspiration Needle

  Class II

  FDA 510(k) K974766 Active Cleared 8 Jan 1998

• Pbn Drainage Catheter Guidewires

  Class II

  FDA 510(k) K991097 Active Cleared 23 Apr 1999

• Md Tech Biopsy Set for Bone and Bone Marrow Open recall

  Class II

  FDA 510(k) K980196 Active Cleared 3 Feb 1998

See all devices from Medical Device Technologies, Inc. →