FDA Device Recall Z-0028-2013: Remington Medical Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0028-2013.

Recall Res Number

Z-0028-2013

Recalling Firm / Manufacturer

Remington Medical Inc.

FEI Number

1000132370

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2012-08-29

Date Posted

2012-10-09

Date Terminated

2013-01-15

Product Code

KNW

Event Number

63070

Product Quantity

800 needles

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.

Reason for Recall Sterility of the product may be compromised.

Action Details 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.

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

Code Information / Serial Numbers NAC-1820M, Lot number: 121003

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Medical Device Recall: Z-0028-2013

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer