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"J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone ...

FDA Recall #Z-0814-2019 — Class II — December 18, 2018

Recall #Z-0814-2019 Date: December 18, 2018 Classification: Class II Status: Terminated

Product Description

"J" Type Bone Marrow Needle 11ga 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

9,900 units

Distribution

Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.

Code Information

Model Number IMKBMN-11R-10-X, Lot Numbers LJUE, LEAC, LFKX; Model Number IMKBMN-11R-10, Lot Numbers LK0J, LEHU

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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