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Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 2...

FDA Recall #Z-0797-2013 — Class II — November 26, 2012

Recall #Z-0797-2013 Date: November 26, 2012 Classification: Class II Status: Terminated

Product Description

Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

Reason for Recall

Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.

Recalling Firm

Custom Healthcare Systems, Inc. — Richmond, VA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

80 trays

Distribution

USA Nationwide Distribution including the states GA, OH, GA, NC and ME.

Code Information

LOT NO. 60812 EXPIRES: 11 /2012

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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