Z-0817-2019 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
500 units

Product Description

Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm

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 BMNJ-MEC-1110, Lot Number LHT1