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.
FDA Recall Z-0028-2013 · Posted 2012-10-09
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Recalling FirmRemington Medical Inc.
Recall StatusTerminated
Product CodeKNW
Date Initiated2012-08-29
Date Terminated2013-01-15
Product Quantity800 needles
Reason for Recall
Sterility of the product may be compromised.
Firm Action
The firm, Remington Medical, Inc., sent an "URGENT - MEDICAL DEVICE RECALL" letter dated August 29, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the products; complete and return the FaxBack form via Fax to: Quality Engineer Remington Medical, Inc., at 770-887-0732 or email: [email protected]; and call the Quality Engineer or customer service at (800) 989-0057 ext 233 to obtain a RGA number and have a call tag issued.
Should you have any questions, please do not hesitate to call the Quality Engineer at (800) 989-0057 ext 233.
Root Cause
Material/Component Contamination
Distribution Pattern
Nationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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