FDAClass IIFebruary 13, 2019

Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x recall

Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm

Why was Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 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 UCIN-11-10, Lot Number LFDB

Product
Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm
Recalling firm
Angiotech (Manan Medical Products, Inc.)
Quantity
2,502 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