FDAClass IIFebruary 13, 2019

Aguja de Aspiracion con Profundidad Ajustable Tipo I recall

Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

Why was Aguja de Aspiracion con Profundidad Ajustable Tipo I 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-16-5, Lot Number LK2L

Product
Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Recalling firm
Angiotech (Manan Medical Products, Inc.)
Quantity
1,404 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