Civco recalled over sterility concerns

Recall date

December 11, 2014

Source

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

Official notice title

Med Tec Inc recalls Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20…

Recall number

Z-0989-2015

FDA classification

Class II

Brand / firm

Med Tec Inc

Sold / distributed

Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.

Why it was recalled

The product (wool wrist loop) was manufactured 7cm shorter than product specifications.

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

What was recalled

Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.