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. |
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| 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. |
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