Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Cour
FDA device recall Z-0028-2013 · posted 2012-10-09 · Terminated
Recall details
- Recalling firm
- Remington Medical Inc.
- Reason for recall
- Sterility of the product may be compromised.
- Action taken
- 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 hesitate to call the Quality Engineer at (800) 989-0057 ext 233.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 800 needles
- Distribution
- Nationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX.
- Date initiated
- 2012-08-29
- Date posted
- 2012-10-09
- Date terminated
- 2013-01-15
- Location
- Alpharetta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROSTATE BIOPSY NEEDLE (K982401) | Remington Medical, Inc. | 1998-09-08 |