J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Mar...
FDA Recall #Z-0815-2019 — Class II — December 18, 2018
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
Recalling Firm
Angiotech (Manan Medical Products, Inc.) — Wheeling, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,260 units
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated