FDA Device

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

Hazard

Pouches were not sealed prior to sterilization.

What You Should Do

Remedy

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.

Products

Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005.
Brand
Remington Medical Inc.
UPC
Lot: 063533

Units Affected

192 units