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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Product Detail

Product Description Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Recall Number Z-0028-2013
Classification Class II
Code Info NAC-1820M, Lot number: 121003
Product Distributed Qty 800 needles
Reason For Recall Sterility of the product may be compromised.

Event Detail

Event Id 63070
Product Type Devices
Status Ongoing
Recalling Firm Remington Medical Inc.
City Alpharetta
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX.