AVID TruCustom MINOR PROCEDURE 6A convenience kits recalled over foreign material

Recall date

June 22, 2017

Source

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

Official notice title

Avid Medical, Inc. recalls AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01

Recall number

Z-0794-2018

FDA classification

Class II

Brand / firm

Avid Medical, Inc.

Sold / distributed

Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

Why it was recalled

Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

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

What was recalled

AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01