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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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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
Distribution Pattern Nationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. NAC-1820M, Lot number: 121003 Class II Sterility of the product may be compromised. 800 needles Z-0028-2013