Customed, Inc recalls BREAST PACK-BOD 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound hea…

Recall date

July 10, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2663-2015

FDA classification

Class II

Brand / firm

Customed, Inc

Sold / distributed

Distributed Only in Puerto Rico.

Why it was recalled

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BREAST PACK-BOD 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .