Recall Z-0028-2013 ยท KNW Instrument, Biopsy
Remington Medical Inc.
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
| Date | Oct 9, 2012 (initiated Aug 29, 2012) |
| Status | Terminated |
| Reason | Sterility of the product may be compromised. |
| Root cause | Material/Component Contamination |
| 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: tracyw@remmed.com; 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 h |
| Quantity | 800 needles |
| Distribution | Nationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982401 | PROSTATE BIOPSY NEEDLE Remington Medical, Inc., Sep 8, 1998 |