Home / Recalls / Angiotech (Manan Medical Products, Inc.) / Z-0815-2019

Z-0815-2019 Class II Terminated

Recalled by Angiotech (Manan Medical Products, Inc.) — Wheeling, IL

Recall Details

Product Type
Devices
Report Date
February 13, 2019
Initiation Date
December 18, 2018
Termination Date
August 23, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,260 units

Product Description

J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

Reason for Recall

Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

Distribution Pattern

Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.

Code Information

Model Number IMKBMN-13R-10, Lot Numbers LF69, LFDA, LFL1

Other recalls by Angiotech (Manan Medical Products, Inc.)

  • Z-0820-2019 Class II — Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Us (December 18, 2018)
  • Z-0818-2019 Class II — Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usa (December 18, 2018)
  • Z-0817-2019 Class II — Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 1 (December 18, 2018)
  • Z-0816-2019 Class II — J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instrume (December 18, 2018)
  • Z-0814-2019 Class II — "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical inst (December 18, 2018)
  • Z-0819-2019 Class II — Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm (December 18, 2018)