Customed, Inc recalls Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedu…

Recall date

January 7, 2016

Source

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

Recall number

Z-1426-2016

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

Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.