FDAClass IIFebruary 13, 2019

Double Diamond J Type Bone Marrow Needle & Marrow recall

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

Why was Double Diamond J Type Bone Marrow Needle & Marrow recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number BMNJ-MEC-1110, Lot Number LHT1

Product
Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm
Recalling firm
Angiotech (Manan Medical Products, Inc.)
Quantity
500 units
Distribution
Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.
Recall date
February 13, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls