Md Tech Biopsy Set for Bone and Bone Marrow

• 3 recalls, same reason

  • Ongoing Z-2709-2026 FDA Class I ·initiated 1 Jun 2026
  • Ongoing Z-2706-2026 FDA Class I ·initiated 1 Jun 2026
  • Ongoing Z-2707-2026 FDA Class I ·initiated 1 Jun 2026

  Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

• 3 recalls, same reason

  • Terminated Z-1196-2017 FDA Class II ·initiated 18 Jan 2017
  • Terminated Z-1194-2017 FDA Class II ·initiated 18 Jan 2017
  • Terminated Z-1195-2017 FDA Class II ·initiated 18 Jan 2017

  The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.

• • Terminated Z-2189-2015 FDA Class II ·initiated 18 Jun 2015

  Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.

• • Terminated Z-2019-2010 FDA Unclassified (pre-2012) ·initiated 1 Sep 2009

  Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Access Needles, Galactography Kit, Stabilization Needles and Needle Guides for packaging integrity.

• 4 recalls, same reason

  • Terminated Z-0451-2009 FDA Unclassified (pre-2012) ·initiated 16 Jul 2008
  • Terminated Z-0453-2009 FDA Unclassified (pre-2012) ·initiated 16 Jul 2008
  • Terminated Z-0450-2009 FDA Unclassified (pre-2012) ·initiated 16 Jul 2008
  • Terminated Z-0452-2009 FDA Unclassified (pre-2012) ·initiated 16 Jul 2008

  Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.

510(k) Number

K980196 ↗

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

• Medical Device Technologies Manual Biopsy Needle

  Class II

  FDA 510(k) K944837 Active Cleared 14 Oct 1994

See all devices from Medical Device Technologies, Inc. →