Prostate Biopsy Needle…

Date posted by the FDA

March 29, 2007

Status

Terminated

Filed by

Remington Medical Inc.

Product

Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005.

Reason

Pouches were not sealed prior to sterilization.

Distribution pattern

Nationwide.

Quantity

192 units

Codes and lots

Lot: 063533

Recall started

Jan. 19, 2007

Device type

Instrument, Biopsy

Root cause (FDA)

Other

What the company told customers

Consignees were contacted by telephone on 01/19/2007. Each customer was informed the sterility of the product may be compromised as a result of unsealed pouches and requested to visually check their inventory.

Recall number

Z-0673-2007

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0673-2007. The agency record governs; check it and the company before acting.